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Sr. Statistical Programmer -REMOTE 8-10 years
Science & Biotech - REMOTE, NJ 07920

MUST HAVE 8-10 YEARS EXPERIENCE • Provide programming support for some or all of the following activities related to clinical trials data: Creation of SDTM and ADaM domains, statistical report generation, and program validation. • Communicate effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget. Proficient in SAS, SQL, or PL/SQL. KNOWLEDGE/SKILLS/ABILITIES (KSA’s): • Good communication skills and ability to supervise others. • Thorough knowledge of clinical trial statistical progra...

View Sr. Statistical Programmer -REMOTE 8-10 years Job - REMOTE, NJ 07920
Sr. Statistical Programmer, Senior Statistical Programmer, SDTM, ADaM, CDISC, CFR, FDA, SAS, Biotechnology, mathematics, computer science, BS, Bachelors Degree,
Flow Cytometry Technologists
Science & Biotech - Jupiter, FL 33410

**FLOW CYTOMETRY JOB OPPORTUNITIES IN CALIFORNIA, TENNESSEE, TEXAS, GEORGIA AND FLORIDA** Perform daily flow cytometric processing for Leukemia/Lymphoma and PNH testing.A^ Utilizing the cytometer software, perform data acquisition of patient samples.A^ Assist, as needed, with data analysis of the processed samples.A^ Assist with routine maintenance and troubleshooting.A^ Perform daily QC/QA involved with the operation of the Flow Cytometry Laboratory.A^ Assist with validation projects. Job Functions: 1. Sample Preparation: Identify, lyse, a...

View Flow Cytometry Technologists Job - Jupiter, FL 33410
flow cytometry, med tech, medical technologist, ascp, lab, laboratory technologist, supervisor
Manager- Biostatistics
Science & Biotech - basking ridge, NJ 07920

The Biostatistics and Data Management group is looking for a Biostatistician to support Clinical Development and Exploratory Sciences. This a position with high visibility for a qualified statistician with experience in the pharmaceutical/biotechnology sector, to collaborate in cross-functional drug development teams to develop and execute innovative statistics for the development of strategy and analysis of clinical trial studies. Responsibilities: • The incumbent will work with the VP of the development strategy and analysis, who will select and...

View Manager- Biostatistics Job - basking ridge, NJ 07920
biostatistician, sr. biostatistician, statistician, sr. statistician, SAS, PhD, manager
Sr. Clinical Trial Assistant
Science & Biotech - Arden Hills , MN 55112

Your responsibilities will include: • Site Start-Up: works across several studies to ensure all required documentation is in place to authorize sites for study enrollment. Partner with other team members to support patient enrollment. • Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence. • Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with p...

View Sr. Clinical Trial Assistant Job - Arden Hills , MN 55112
Clinical Lab/Medical Director (molecular)
Science & Biotech - Bethlehem, PA 18015

Seeking a Clinical Laboratory/Medical Director for a genomics laboratory. This role is responsible for current and future clinical genomic testing provision and development. The selected candidate must possess a; MD, PhD or MD/PhD Appropriate experiences and expertise that would ensure success of the genomics laboratory The candidate must qualify as a CLIA laboratory director and be eligible for a New York State COQ. Specific expertise in clinical laboratory genetics is required and, in conjunction with an experienced scientif...

View Clinical Lab/Medical Director (molecular) Job - Bethlehem, PA 18015
abmg, cytogenetics, molecular, director, geneticist, fish, genetics, laboratory, american society of clinical pathology, pathology, american boards of medical genetics, nycoq
Senior Analyst- Data Standards- REMOTE
Science & Biotech - remote, CA 92115

Permanent position Develop, implement and maintain end-to-end data standards from data collection to regulatory submission. Ensuring traceability throughout the data process and ensuring submission datasets conform to the data standards expected by regulatory agencies. Key Responsibilities Includes: Responsible for compliance with applicable Corporate and Divisional Polices and procedures Industry Standards - Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides as well as FDA guidance and r...

View Senior Analyst- Data Standards- REMOTE Job - remote, CA 92115
Analyst, FDA, CDASH, CDISC, ADaM, SDTM, Senior, Senior Analyst,
Sr. Statistical Programmer -REMOTE
Science & Biotech - remote, CA 92104

Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large observational databases (e.g., administrative claims and electronic medical records) and observational research/epidemiology statistical methods is strongly desired. Experience with the Hadoop data storage platform and the OMOP Common Data Model also strongly desired. Strong doc...

View Sr. Statistical Programmer -REMOTE Job - remote, CA 92104
SAS, OMOP, Bachelor's Degree, Sr. Study Programmer, epidemiology, Hadoop, medical claim, medicare, EMR, Medicaid, healthcare , SQL
Lead Biostatistician- REMOTE
Science & Biotech - remote, CA 22434

Writing/implementing simulation programs after receiving requirements Proactively raise and ask questions Prior experience as the lead statistician with the ability to lead projects through completion Ability to understand clinical trial studies Good at both SAS and R programming Basic Qualifications: • Master’s degree in Statistics/Biostatistics or other subject with high statistical content with 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics o...

View Lead Biostatistician- REMOTE Job - remote, CA 22434
biotech, biotechnology, lead, lead biostatistician, biostatistician, CDISC, ADaM, Protocol, DRT/DMC, SAP, RPP, Masters,
QC Data Reviewer
Science & Biotech - Durham, NC 27709

Description Technical review of raw data for the QC group Technical review of method transfer/verification protocols Technical writing of specification documents, standard test procedures, general test procedures, SOPs, qualification protocols Review, manage, and monitor stability trend tables Support investigations that arise in the QC testing of raw materials/finished products as needed Work with all parties as applicable, technical services, material management, manufacturing, packaging, and the laboratory to identify the breadth and scop...

View QC Data Reviewer Job - Durham, NC 27709
Environmental Monitor
Science & Biotech - Durham, NC 27710

Responsibilities Support the onboarding/qualification of new Microbiology lab Environmental monitoring of cGMP controlled areas. Total particulate count monitoring of controlled areas. Sampling and testing of pharmaceutical grade water. Microbial identifications, Growth promotion, Bioburden, Endotoxin, Biological Indicator, and Sterility testing. Support the onboarding/qualification of new Micro laboratory equipment Proficiently perform all qualified testing methods used by the Microbiology department. Perform all other duties assigned Qualif...

View Environmental Monitor Job - Durham, NC 27710
Oncology Clinical Project Managers
Science & Biotech - Morris Plains, NJ 07950

Our client, a global CRO, is currently looking for TWO senior clinical project managers with strong Oncology experience! Great opportunity to work part-time from home, and 2-3 days on site with a smaller, growing sponsor company. Best of both worlds for a work life balance! EXCELLENT, FULL TIME COMPENSATION package available for these roles! Job Responsibilities: Act as primary liaison with clients. Lead and direct cross-functional team leaders and third parties/vendors with some supervision and support. Manage project contractual deliverab...

View Oncology Clinical Project Managers Job - Morris Plains, NJ 07950
oncology, clinical trials, project management, sponsor, CRO, global clinical research
Home-based Pharmaceutical Clinical Trial Agreements Contracts Analyst
Science & Biotech - Philadelphia, PA 19101

Opportunity to work in the clinical trial agreements and contracts area for a leading global pharmaceutical company. JOB DESCRIPTION: Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grant...

View Home-based Pharmaceutical Clinical Trial Agreements Contracts Analyst Job - Philadelphia, PA 19101
Clinical Trial Agreements, Contracts, Agreements, Budgets, Pharmaceutical, Clinical Research, GCP, Negotiation, Grants, J.D., Juris Doctor, Law Degree, Paralegal
Home-based Pharmaceutical Clinical Trial Agreements Contracts Analyst
Science & Biotech - Durham, NC 27703

Opportunity to work in the clinical trial agreements and contracts area for a leading global pharmaceutical company. JOB DESCRIPTION: Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grant...

View Home-based Pharmaceutical Clinical Trial Agreements Contracts Analyst Job - Durham, NC 27703
Clinical Trial Agreements, Contracts, Agreements, Budgets, Pharmaceutical, Clinical Research, GCP, Negotiation, Grants, J.D., Juris Doctor, Law Degree, Paralegal
Pharmaceutical Drug Safety Associate - SF Bay Area
Science & Biotech - San Francisco, CA 94101

We have a very well established pharmaceutical client located by SFO airport and they are looking for people to work in Pharmacovigilance/Drug Safety in triage workflow, intake, submissions and drug safety quality. Drug Safety Associate Primary Responsibilities Submissions activities also apply to Ethics Committee (EC) reporting as well as distribution of Investigator safety letters. A dashboard that tracks compliance is handled internally via compliance metrics report and provided to the QPPV. Submissions activities include both ICSR...

View Pharmaceutical Drug Safety Associate - SF Bay Area Job - San Francisco, CA 94101
Drug Safety, Pharmacovigilance, RN, Nurse, SAE's, Serious Adverse Events, PSUR, DSUR, Queries, MedDRA, Argus, Triage, ICSR, ArisG, Clintrace, Drug Coding, Intake, Submissions, Case Registration, Case Receipt
Home-based Pharmaceutical Clinical Trial Agreements Contracts Manager
Science & Biotech - New York, NY 10017

Opportunity to work in the clinical trial agreements and contracts area with a leading global pharmaceutical company. DESCRIPTION Responsibilities will include, but are not limited to, the following: Perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol. Deliver clinical site agreements that protect company business interests and compliance with regulations and laws concerning the same including compliance with Fair Market Value (“FMV”). 1. Support G...

View Home-based Pharmaceutical Clinical Trial Agreements Contracts Manager Job - New York, NY 10017
Clinical Trial Agreements, Contracts, Agreements, Budgets, Pharmaceutical, Clinical Research, GCP, Negotiation, Grants, J.D., Juris Doctor, Law Degree, Paralegal
Home-based Pharmaceutical Clinical Trial Agreements Contracts Manager
Science & Biotech - Philadelphia, PA 19101

Opportunity to work in the clinical trial agreements and contracts area with a leading global pharmaceutical company. DESCRIPTION Responsibilities will include, but are not limited to, the following: Perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol. Deliver clinical site agreements that protect company business interests and compliance with regulations and laws concerning the same including compliance with Fair Market Value (“FMV”). 1. Support G...

View Home-based Pharmaceutical Clinical Trial Agreements Contracts Manager Job - Philadelphia, PA 19101
Clinical Trial Agreements, Contracts, Agreements, Budgets, Pharmaceutical, Clinical Research, GCP, Negotiation, Grants, J.D., Juris Doctor, Law Degree, Paralegal
Home-based Pharmaceutical Clinical Trial Agreements Contracts Manager
Science & Biotech - Durham, NC 27703

Opportunity to work in the clinical trial agreements and contracts area with a leading global pharmaceutical company. DESCRIPTION Responsibilities will include, but are not limited to, the following: Perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol. Deliver clinical site agreements that protect company business interests and compliance with regulations and laws concerning the same including compliance with Fair Market Value (“FMV”). 1. Support G...

View Home-based Pharmaceutical Clinical Trial Agreements Contracts Manager Job - Durham, NC 27703
Clinical Trial Agreements, Contracts, Agreements, Budgets, Pharmaceutical, Clinical Research, GCP, Negotiation, Grants, J.D., Juris Doctor, Law Degree, Paralegal
Pharmaceutical Clinical Trial Agreements Contracts Manager
Science & Biotech - San Francisco, CA 94101

Objective of Position This strategic and collaborative role oversees site and other trial-related contracts. This role supports clinical development programs across all functional areas and is responsible for the management and processing of CDAs, Consulting Services Agreements, and Clinical Trial Agreements. Contracts are negotiated and completed in timely manner to meet clinical site activation timelines and functional deliverables. The contracts manager is accountable for working with internal and external partners to communicate challenges, ri...

View Pharmaceutical Clinical Trial Agreements Contracts Manager Job - San Francisco, CA 94101
Clinical Trial Agreements, Contracts, Agreements, Budgets, Pharmaceutical, Clinical Research, GCP, Negotiation, Grants, J.D., Juris Doctor, Law Degree, Paralegal
Clinical Trial Assistant
Science & Biotech - Summit, NJ 07901

Summary/Scope: The Clinical Trial Associate (CTA) in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors. Responsibilities invol...

View Clinical Trial Assistant Job - Summit, NJ 07901
Clinical Trial Manager
Science & Biotech - Princeton , NJ 08541

The Clinical Trial Manager is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable company to maximize efficient and timely delivery of clinical trials. This position is responsible for contributing to an industry leading site engagement team. The Clinical Trial Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following: • Define and implement strategies for enga...

View Clinical Trial Manager Job - Princeton , NJ 08541
Clinical Trial Manager
Science & Biotech - North Wales , PA 19454

The Clinical Trial Manager is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable company to maximize efficient and timely delivery of clinical trials. This position is responsible for contributing to an industry leading site engagement team. The Clinical Trial Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following: • Define and implement strategies for enga...

View Clinical Trial Manager Job - North Wales , PA 19454
Sr. Analyst - Functional Planning
Science & Biotech - Titusville , NJ 08560

Position Overview: Sr. Analyst – Clinical Functional Planning will be accountable for the day-to-day maintenance of data in planning systems (ex. Planisware / 1-Supply / Beacon / SharePoint / UCT / etc.). Under supervision of a group manager, he/she will support variety of operational activities (ex. functional detailed forecasting of work deliverables, drivers, names assignments, algorithms, reason codes, manual updates as needed). The candidate will use and maintain accurate functional project and non-project plans, track functional resourcing (FT...

View Sr. Analyst - Functional Planning Job - Titusville , NJ 08560
Sr. Analyst - Functional Planning
Science & Biotech - Raritan , NJ 08869

Position Overview: Sr. Analyst – Clinical Functional Planning will be accountable for the day-to-day maintenance of data in planning systems (ex. Planisware / 1-Supply / Beacon / SharePoint / UCT / etc.). Under supervision of a group manager, he/she will support variety of operational activities (ex. functional detailed forecasting of work deliverables, drivers, names assignments, algorithms, reason codes, manual updates as needed). The candidate will use and maintain accurate functional project and non-project plans, track functional resourcing (FT...

View Sr. Analyst - Functional Planning Job - Raritan , NJ 08869
Executive Administrative Assistant
Science & Biotech - Billerica , MA 01822

Job Title: Executive Administrative Assistant Your role: As the Executive Assistant, you will provide high-level administrative support to the Executive VP and basic administrative support to the VPs team. In this role, you'll develop broad and comprehensive experience, skills and knowledge in organizational policies, procedures and practices. You will also facilitate and coordinate projects and deadlines directly or in collaboration with others. You will work independently, and carry out large scale special assignments, with minimal supervision. M...

View Executive Administrative Assistant Job - Billerica , MA 01822
Sr. Analyst - Functional Planning
Science & Biotech - Springhouse , PA 19477

Position Overview: Sr. Analyst – Clinical Functional Planning will be accountable for the day-to-day maintenance of data in planning systems (ex. Planisware / 1-Supply / Beacon / SharePoint / UCT / etc.). Under supervision of a group manager, he/she will support variety of operational activities (ex. functional detailed forecasting of work deliverables, drivers, names assignments, algorithms, reason codes, manual updates as needed). The candidate will use and maintain accurate functional project and non-project plans, track functional resourcing (FT...

View Sr. Analyst - Functional Planning Job - Springhouse , PA 19477
Contracts Administrator
Science & Biotech - Burlingame, CA 94010

Job Title: (TEMP) Assoc. Contracts Manager, Contracts/Sr. Contracts Administrator/Contracts Administrator Department: Legal Affairs KindredBio is a veterinary biopharmaceutical company dedicated to saving and improving the lives of companion animals. This position will be part of the legal team and reports to the Director of Legal Affairs. The position will be responsible for (i) ensuring that KindredBio contracts meet legal standards and client requirements, (ii) support in-house counsel and external counsel with various legal matters, includ...

View Contracts Administrator Job - Burlingame, CA 94010
Senior Manager Statistical Programming
Science & Biotech - Marlborough, MA 01752

Senior Manager, Statistical Programming, onsite, Marlborough, MA - Provide statistical programming support to clinical trials for regulatory submissions and various publications, posters, … etc. - Support the Biostatistics function in statistical analysis including generating analysis data sets, patient listings, tables and figures for clinical trials. - Develop and maintain the infrastructure for project files of SAS datasets and SAS programs. Essential Functions: 1. Provide statistical programming support to clinic...

View Senior Manager Statistical Programming Job - Marlborough, MA 01752
5-7 years programming experience in the pharmaceutical industry or equivalent experience, CDISC, SDTM and ADaM experience, lead programming experience, NDA, sNDA submissions and ISS/ISE experience.
Biostatistician Manager, onsite (PhD required)
Science & Biotech - Basking Ridge, NJ 10591

Salary up to 140K, Willing to pay for relocation, Offers free paid time off the week in between Christmas and the new year, open to Visa sponsorship, However US citizenship preferred given the delay in start-time to sponsor individuals. This position is based in either site Tarrytown, NY, or Basking Ridge, NJ offices. Note: The other 'CNS' biostatistician position must be based in Basking Ridge 'only'. Summary: The Biostatistics and Data Management group is looking for a Biostatistician to support Clinical Development and Exploratory Sciences. Th...

View Biostatistician Manager, onsite (PhD required) Job - Basking Ridge, NJ 10591
statistical analyses, statistical methodologies, sample size calculations, write statistical sections for protocols, analyzing data from efficacy, parallel, cross-over, pharmacokinetic and dose-response studies, Manage biostatistics CRO, Bayesian methodology, data mining or machine learning algorithm. Familiarity with JAGS, R –Shiny, C++ and high performance scientific computing will be a plus.
Lead Clinical Data Manager
Science & Biotech - Durham, NC 14353

The Lead Data Manager performs data management activities for both clinical and development projects. Ensures the delivery of complete, accurate data that is ready for analysis and regulatory submissions' defines and applies study-specific data requirements; participates in database planning and user acceptance testing of databased; and organizes and facilitates data entry and data management tasks to ensure timely, hlqh-qualitv deliverables. • Functions as Lead Data Manager for assigned projects, acting as the primary point of contact for...

View Lead Clinical Data Manager Job - Durham, NC 14353
Sr. Data Manager
Science & Biotech - Rockville, MD 20850

+++This position will be 100% on-site+++ Lead and conduct all DM activities required for global clinical trials. Coordinate the work of global staff assigned to the project. Provide training on procedures and systems. . Create project-related materials. Track project progress and issue status reports. Ensure the achievement of key milestones relating to the function, such as completion of tasks towards final database. Attend internal and external meetings. May be required to participate in client, internal or agency audits and inspections M...

View Sr. Data Manager Job - Rockville, MD 20850
Principal Engineer, GMP Manufacturing Pharmaceutical Development
Science & Biotech - Durham , NC 27703

Our client, a growing global pharmaceutical company, is currently hiring a Principal Engineer, Implant Manufacturing based in their Research Triangle Park, North Carolina headquarters. The person in this newly-created position will be responsible for leading the manufacturing of their extended-release, sterile, ophthalmic products from early pre-clinical development through phase 3 clinical studies. Essential Duties & Responsibilities: This position will be responsible for leading the transition of drug product manufacturing processes from the for...

View Principal Engineer, GMP Manufacturing Pharmaceutical Development Job - Durham , NC 27703
Molecular Genetic Supervisor
Science & Biotech - Dallas, TX 75001

JOB DESCRIPTION Perform and direct procedures and functions within the Molecular Genetics department. Provides direct supervision of Molecular Technologists and the testing they perform. Maintains departmental QA/QC and inspection readiness. RESPONSIBILITIES Day to day supervision of test performance and testing personnel. Monitoring examinations to ensure that acceptable levels of analytic performance are maintained. Assure that all remedial actions are taken whenever test systems deviate from the laboratory's established p...

View Molecular Genetic Supervisor Job - Dallas, TX 75001
molecular, genetics, molecular supervisor, laboratory, technologist
Contract Sr. Programmer- Descriptive Epidemiology
Science & Biotech - Remote, CA 94123

The senior statistical programmer position will be responsible for manipulating large databases and generating reports using SAS to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large databases and observational research methods such as epidemiology and statist...

View Contract Sr. Programmer- Descriptive Epidemiology Job - Remote, CA 94123
Sr. SAS Programmer, SAS Programmer, Statistical Programmer, Epidemiology, Epi Programmer, Analyst, HEOR, Healthcare, Real World Data, real World Healthcare Data, Observational Research
Remote Contract- Sr. SAS Programmer (Oncology)
Science & Biotech - Remote, NC 27602

- 6 month renewable contract- Pharmaceutical Client - Remote - Required to work pacific hours Required Previous Experience Includes: *Oncology experience required Creation of datasets and Tables or QC of these outputs Both safety and efficacy (AE tables all types, Lab shift tables, Exposure tables, PFS, OS, DOR, ORR, TTE) Experience in generating figures (Kaplan Meier, forest plot, waterfall) SDTM, ADAM, SAS 9.4, BASE, ODS, SAS/STAT, SAS/GRAPH, SAS Macro

View Remote Contract- Sr. SAS Programmer (Oncology) Job - Remote, NC 27602
Sr. SAS Programmer, SAS Programmer, Statistical Programmer, Clinical Programmer
Clinical Trial Manager
Science & Biotech - Rectangle Triangle Park , NC 27709

The Clinical Trial Manager is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable company to maximize efficient and timely delivery of clinical trials. This position is responsible for contributing to an industry leading site engagement team. The Clinical Trial Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following: • Define and implement strategies for enga...

View Clinical Trial Manager Job - Rectangle Triangle Park , NC 27709
Associate Cytogenomics Director (ABMG Molecular OR Cytogenetic required)
Science & Biotech - Germantown, MD 20874

The Associate Director will support and expand the clinical microarray program. Responsibilities: Serves as an expert for review, interpretation and sign-out of microarray results. Reviews, interprets and reports other assays used for detection of copy number variants such as MLPA and qPCR. Provides skilled management and interpretation of complex copy number variant cases Assists with improvement to analysis and reporting workflows Assist with training of analysts when new practices are established Manages laborat...

View Associate Cytogenomics Director (ABMG Molecular OR Cytogenetic required) Job - Germantown, MD 20874
abmg, cytogenetics, molecular, director, geneticist, fish, genetics, laboratory, american society of clinical pathology, pathology, american boards of medical genetics
Director of Data Standards (perm onsite MA, CDISC )
Science & Biotech - Marlborough, MA 01752

Location MA Job type Full-time Summary of Responsibilities Work to create/maintain library of company metadata standards, including CRFs, Datasets, Variables, Value List, Controlled Terminology, Computation Method definitions in a single, easy to navigate repository that describes the data standards targets. Work to keep abreast of and incorporate new and updated data standards issued by CDISC and other Standards Development Organizations (SDO) which impact data processing activities within Data Science and other R&D functions that proce...

View Director of Data Standards (perm onsite MA, CDISC ) Job - Marlborough, MA 01752
knowledge of current and planned FDA data submissions requirement, knowledge of regulatory guidelines and industry standards (FDA/CFR, ICH/GCP, CDISC, PhUSE), Experience with implementing/working with metadata repositories/management systems is highly desirable CDISC training/experience is a requirement, Experience creating CDISC SDTM and ADaM datasets and strong familiarity with CDISC Controlled Terminology is highly desirable, Knowledge of CDISC SEND model is desirable
Remote Clinical Epidemiology SAS programmer (OMOP and/or Hadoop trained or experience)
Science & Biotech - Remote, NC 27513

The senior statistical programmer position will be responsible for manipulating large databases and generating reports using SAS to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large databases and observational research methods such as epidemiology and statist...

View Remote Clinical Epidemiology SAS programmer (OMOP and/or Hadoop trained or experience) Job - Remote, NC 27513
genetic databases such as TCGA or UK Biobank database programming experience, DRG, MarketScan, Optum, PharMetrics, Medicare and EMR databases, Hadoop database platform and Impala or Hive SQL, SAS and SQL programming skills and an understanding of healthcare databases in a relational database structure. Prior experience with medical coding terminology, coding complex cohort definitions and the OMOP common data model
senior manager SAS programmer
Science & Biotech - Marlborough, MA 01752

Marlborough, MA, PERM, onsite Senior Manager, Statistical Programming - Provide statistical programming support to clinical trials for regulatory submissions and various publications, posters, … etc. - Support the Biostatistics function in statistical analysis including generating analysis data sets, patient listings, tables and figures for clinical trials. - Develop and maintain the infrastructure for project files of SAS datasets and SAS programs. Essential Functions: 1. Provide statistical programming su...

View senior manager SAS programmer Job - Marlborough, MA 01752
5-7 years programming experience in the pharmaceutical industry or equivalent experience, CDISC, SDTM and ADaM experience, lead programming experience, NDA, sNDA submissions and ISS/ISE experience.
Director/Senior Director, Medical Affairs Ophthalmology
Science & Biotech - Bedminster, NJ 07921

Overall Purpose: Responsible to work in close collaboration with the V.P. Clinical Research, Medical and Professional Affairs to align with the leaders of commercial operations, clinical and regulatory to execute the strategic efforts of Medical Affairs in support of pre-launch, branded and late – stage products, as well as manage the organizational planning and operational needs of the Medical Affairs organization. Duties and Responsibilities: Medical Affairs: • Oversee development of post-marketing clinical development plans including phase ...

View Director/Senior Director, Medical Affairs Ophthalmology Job - Bedminster, NJ 07921
medical affairs, vice president, glaucoma, ophthalmology, pharmaceutical, clinical research
Molecular Pathologist
Science & Biotech - Nashville, TN 37011

RESPONSIBILITIES: • Molecular Genetics/Pathology • Ability to interpret the clinical significance of genomic variants • Ability to synthesize summaries on complex genomic mutation profiles • Ability to make complex scientific judgments • Provides consultations to care providers. • Write and sign molecular genetic reports summarizing analyses, results, and conclusions. • Works with laboratory staff to address clinical issues promptly. • Assist with the planning and implementation of the quality control and quality assurance programs. • Assist ...

View Molecular Pathologist Job - Nashville, TN 37011
pathology, AP/CP, anatomic pathology, clinical pathology, hospital, laboratory, director, lab, molecular, abmg, pathologist
Associate Molecular/Cytogenetic Director
Science & Biotech - Nashville, TN 37011

**Dual boarded is preferred. We would like someone that can do a 75/25 split MDX/cytogenetics. A really good candidate for MDX only would also be considered. The Associate Director of Molecular Diagnostics assists with the strategic maintenance/development of the Molecular Diagnostic laboratory.** JOB RESPONSIBILITIES Writing and reporting: Cytogenetics / FISH /microarray cases. Assists in strategic development of the laboratory services. Assists in the development and implementation of polices and procedures that guide and suppo...

View Associate Molecular/Cytogenetic Director Job - Nashville, TN 37011
abmg, cytogenetics, molecular, director, geneticist, fish, genetics, laboratory, american society of clinical pathology, pathology, american boards of medical genetics
Software Development Engineer
Science & Biotech - Boulder, CO 80306

The Senior Software Development Engineer will be a contributor to the development team, developing software for the Integrated Respiratory Information System, Business Intelligence, and other applications. This position will work as a software development engineer and and help define product specifications, and design, implementation and testing required to effectively allow the applications to consume respiratory medical device and related 3rd party data stored in the SQL data base. As the person in this role develops more experience he/she will pro...

View Software Development Engineer Job - Boulder, CO 80306
Medical device, SQL database, C#, .Net, HTML, JavaScript, Anguar, Typescript, jQuery, Bootstrap, Web 2000, WebAPI, Design control documentation, C++, RESTful, WebAPI, SQL Server, MVC 3.0 or higher, network protocols, mobile apps, Agile or related, AI, Machine Learning
Remote Clinical Epidemiology SAS programmer (OMOP and/or Hadoop trained or experience)
Science & Biotech - Remote, NC 27606

- 12 month renewable contract - Remote Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large observational databases (e.g., administrative claims and electronic medical records) and observational research/epidemiology statistical methods is strongly desired. Experience with the Hadoop data storage platform and the OMOP Common Data...

View Remote Clinical Epidemiology SAS programmer (OMOP and/or Hadoop trained or experience) Job - Remote, NC 27606
OMOP common data model, Hadoop, SAS programming, observational, complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large databases and observational research/epidemiology methods is strongly desired, Epidemiology programming, SAS, pharmacuetical, biotechnology
Director of Data Standards (perm onsite MA, CDISC )
Science & Biotech - Massachusetts, MA 01752

Director of Data Standards, permanent onsite MA, competitive package: salary, bonus, stock options, 401K, relocation available.... Location MA Job type Full-time Summary of Responsibilities Work to create/maintain library of company metadata standards, including CRFs, Datasets, Variables, Value List, Controlled Terminology, Computation Method definitions in a single, easy to navigate repository that describes the data standards targets. Work to keep abreast of and incorporate new and updated data standards issued by CDISC and other Stand...

View Director of Data Standards (perm onsite MA, CDISC ) Job - Massachusetts, MA 01752
clinical trial design and analysis activities and knowledge of regulatory guidelines and industry standards (FDA/CFR, ICH/GCP, CDISC, PhUSE), Director, Data Standards, CDISC controlled terminology, SDTM, ADaM, controlled metadata repositories, implementation of standards, NDA preparation planning
Sr. CRA and CRA II openings - Remote
Science & Biotech - Research Triangle Park , NC 27709

DOCS's is HIRING! Looking for home-based Sr. CRA's and CRA II's. f interested, please forward your resume to Diane Brescia, Sr. Lead Recruiter at DOCS. Her email address is diane.brescia@docsglobal.com. • Geographic requirements – Entire U.S (Must be 1 hour from major airport) • Therapeutic requirements – Will consider all Therapeutic areas • Experience requirements – Greater than 2 years Clinical Research Associate Educational Requirement: Minimum B.S/B.A Degree preferred.

View Sr. CRA and CRA II openings - Remote Job - Research Triangle Park , NC 27709
Senior Biostatistician (Direct hire)
Science & Biotech - San Francisco, CA 94080

Onsite - San Francisco, CA Direct Hire The Senior Biostatistician will provide statistical support (e.g., study design and data analysis) across all clinical studies, pre-clinical, and validation studies. The successful candidate will provide data mining for product development, global regulatory submissions, claims substantiation, post market surveillance, and tracking data optimization. These activities are in direct support of product approval for drugs. Responsibilities: Assist the Director of Biostatistics with the design and analysis ...

View Senior Biostatistician (Direct hire) Job - San Francisco, CA 94080
Demonstrated ability to use of EDC/CTMS databases, Author statistical analysis plans for individual studies, ISS and ISE, CDISC standards across studies and programs, Perform statistical analysis, create summary tables, listings and figures in SAS and validate statistical analysis
Contract Clinical Data Manager
Science & Biotech - Seattle, WA 98109

Onsite - Seattle, WA 6 month renewable contract The Contract Clinical Data Manager will provide data management support for company and partner clinical trials, including out-sourced activities. The Contract Clinical Data Manager will support/lead data management activities from protocol review, through CRF and Database design, trial conduct, and database lock. The incumbent will also have a role in the definition and refinement of departmental procedures and standards, all in accordance with GCP and company SOPs. BS/MS with 5+ years of industry...

View Contract Clinical Data Manager Job - Seattle, WA 98109
support/lead data management activities from protocol review, through CRF and Database design, trial conduct, and database lock, oncology and cell therapy trial
San Diego Senior SAS programmer opening (contract)
Science & Biotech - San Diego, CA 92122

Onsite - San Diego, CA Direct Hire _________________________________________________________ Senior Statistical Programmer Job Description This essential team member will be responsible for supporting the SAS statistical programming efforts for clinical and non-clinical projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of programming standards a...

View San Diego Senior SAS programmer opening (contract) Job - San Diego, CA 92122
write CDISC specifications, write SDTM specifications, Write ADaM specifications, run Open CDISC, define. xml, SAS programming,
Cytogenetic/FISH Technologist
Science & Biotech - Cape Coral, FL 33903

- Preparation of clinical specimens (i.e. bone marrow, peripheral blood and lymph node) for cytogenetic testing, which include setting up the specimens, harvesting, slide making and banding - Screening the G banded slides - Setting up FISH for hematological probes. Washing and screening FISH slides. - Primary responsibilities of a technologist are focused on routine specimen analysis and reporting of results. - Provide overall assistance to the laboratory staff at the discretion of the Laboratory Director or primary supervisor in order to improve ...

View Cytogenetic/FISH Technologist Job - Cape Coral, FL 33903
cytogenetic, cytogenetics, ascp cg, ascp, laboratory, genetics, genetic, nca, American society of clinical pathology, FISH, supervisor, technologist, lead tech, microarray, manager