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In-House CRA/ Clinical Project Specialist
Science & Biotech - San Francisco, CA 94158

The Project Specialist 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. The role requires a thorough and Strategic Understandin...

View In-House CRA/ Clinical Project Specialist Job - San Francisco, CA 94158
Clinical Research
In-House CRA/ Clinical Project Specialist
Science & Biotech - Summit, NJ 07901

The Project Specialist 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. The role requires a thorough and Strategic Understandin...

View In-House CRA/ Clinical Project Specialist Job - Summit, NJ 07901
Clinical Research
ePRO Data Manager
Science & Biotech - Lawerenceville, NJ 08648

Providing support to clinical data management start-up activities across one or more clinical development programs enabling planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance. Gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards, and also responsibility for user acceptance...

View ePRO Data Manager Job - Lawerenceville, NJ 08648
Pharmaceutical Clinical Outsourcing & Vendor Contracts Specialist
Science & Biotech - Boston, MA 02111

Job Description This role manages the outsourcing of clinical development projects to external service providers on behalf of Global Clinical Operations, allowing on-time, on budget and on quality delivery of clinical data to support the potential registration of new products. The role will require the use of advanced analytical skills to review complex clinical study assumptions and budget data and will require business knowledge of the clinical development process and close collaboration with internal and external key stakeholders. Responsibil...

View Pharmaceutical Clinical Outsourcing & Vendor Contracts Specialist Job - Boston, MA 02111
Clinical Trial Agreements, Contracts, Agreements, Budgets, Pharmaceutical, Clinical Research, GCP, Negotiation, Outsourcing, Vendors
Home-based Pharmaceutical Clinical Trial Agreements Contracts Analyst
Science & Biotech - New York, NY 10017

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 - 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 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
Medical Device Regulatory Affairs and Quality Assurance Manager
Science & Biotech - Dallas, TX 75201

We are a smaller medical device company with products marketed globally. Job Purpose Implement regulatory submission strategies and manage regulatory requests for a wide array of regulatory documents, statements and dossiers in coordination with Regulatory HQ. Provide consultation, guidance and recommendations to relevant Company Functions relative to matters of US Regulation and foster constructive interactions with Regulatory Agencies and Certification Bodies. Responsibilities • Implement regulatory compliance strategies in coordinati...

View Medical Device Regulatory Affairs and Quality Assurance Manager Job - Dallas, TX 75201
Medical Device, Regulatory Affairs, Regulatory Submissions, 510(k), PMA, Quality Assurance, QA, ISO 13485, 1SO 14971, MDD, CAPA, internal audits, regulatory, compliance
Sr. Manager, GCP Quality and Regulatory Audits and Inspections
Science & Biotech - New York, NY 10017

This is a new role for the pharmaceutical company where they are looking for a Manager who can help them to prepare for Inspection Readiness. They are filing several new products with the FDA this year and want to have someone who has had experience preparing for FDA, MHRA and other regulatory authority audits associated with filing new products. They want a Project Manager to help them to organize this but this person has to have had Quality Management experience. Summary/Scope: Lead program teams through the activities of preparing for wor...

View Sr. Manager, GCP Quality and Regulatory Audits and Inspections Job - New York, NY 10017
GCP, Good Clinical Practices, QA, Quality Assurance, Auditor, Clinical Research, Clinical Trials, ICH, Pharmaceutical, SOP's
Senior Director - Clinical Trial Operations
Science & Biotech - South San Francisco , CA 94080

Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality. Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles). Work collaboratively with cross functional inte...

View Senior Director - Clinical Trial Operations Job - South San Francisco , CA 94080
Clinical Study Associate
Science & Biotech - Irvine , CA 92606

• Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions. • Creation/distribution of regulatory binders & the wet-ink signed documents binder • Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing correct...

View Clinical Study Associate Job - Irvine , CA 92606
Sr. Statistical Programmer- REMOTE
Science & Biotech - remote, CA 91945

- 12 month long term contract - Remote 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...

View Sr. Statistical Programmer- REMOTE Job - remote, CA 91945
SAS, OMOP, Bachelor's Degree, Sr. Study Programmer, epidemiology, Hadoop, medical claim, medicare, EMR, Medicaid, healthcare , SQL
Sr. Statistical Programmer- REMOTE
Science & Biotech - remote, CA 91945

- 12 month long term contract - Remote 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...

View Sr. Statistical Programmer- REMOTE Job - remote, CA 91945
SAS, OMOP, Bachelor's Degree, Sr. Study Programmer, epidemiology, Hadoop, medical claim, medicare, EMR, Medicaid, healthcare , SQL
Medical Director, Medical Affairs Ophthalmology
Science & Biotech - Irvine, CA 92614

Our client, a growing pharmaceutical company preparing for another exciting launch, is currently looking for a Medical Director, Medical Affairs for their growing team. This position can be based in Irvine, CA or in the Bedminster, NJ area. Responsible to work in close collaboration with the V.P. Medical 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 ...

View Medical Director, Medical Affairs Ophthalmology Job - Irvine, CA 92614
medical affairs, medical director, glaucoma, ophthalmology, pharmaceutical, clinical research
Associate Director, CMC Regulatory Affairs
Science & Biotech - Raleigh, NC 27601

Our client, a growing Oncology pharmaceutical company located in the RTP area, is currently hiring a new position for their growing team! Primary Job Responsibilities: • Lead efforts for coordinating CMC content for original INDs, IND amendments, IMPDs, for inclusion in Clinical Trial Applications and NDAs • Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, DSURs and background documents for Regulatory Authority meetings • Provides strategic CMC regulatory interpretation an...

View Associate Director, CMC Regulatory Affairs Job - Raleigh, NC 27601
CMC, regulatory affairs, regulatory submissions, pharmaceutical, oncology
Director, Clinical Scientist
Science & Biotech - Raleigh, NC 27610

Our client, a growing oncology pharmaceutical company in the RTP area, is currently hiring a new position for their growing team!! The Director Clinical Scientist is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position works independently across functional teams to ensure the timely execution of the clinical development plan. Requires minimal supervision in the development of protocols, analysis of clinical trial data, literature searches, and summary of key data. Clos...

View Director, Clinical Scientist Job - Raleigh, NC 27610
clinical scientist, regulatory submissions, medical writer, protocol author
Principal Statistical Programmer
Science & Biotech - Durham, NC 27701

Principal/Manager level statistical programmer contractor 6 months to hire Location: On-site Durham, NC Our client is a company focus on developing innovative therapies for metabolic disorders. Our current pipeline consists of two investigational drugs under the clinical development stage for the treatment of diabetes. The primary business strategy is to outsource all clinical studies. This position will work collaboratively across clinical development and its external vendors to ensure the efficient, high-quality production of analysis datasets...

View Principal Statistical Programmer Job - Durham, NC 27701
CDISC, ADaM, SDTM, tables, listings, graphs, figures, program validation, output verification, SAS data manipulation, pharmacokinetic and pharmacodynamic datasets
Principle/Manager Statistical Programmer
Science & Biotech - Durham , NC 27701

Job type: Principal/Manager level statistical programmer contractor 6 months to hire Location: On-site Durham, NC Our client is a company focus on developing innovative therapies for metabolic disorders. Our current pipeline consists of two investigational drugs under the clinical development stage for the treatment of diabetes. The primary business strategy is to outsource all clinical studies. This position will work collaboratively across clinical development and its external vendors to ensure the efficient, high-quality production of ana...

View Principle/Manager Statistical Programmer Job - Durham , NC 27701
Principle programmer, manager of statistical programming, CRO, CDISC, ADaM, SDTM, CRF, Biotechnology, Pharmaceutical
CSV Specialist
Science & Biotech - Durham, NC 27710

THIS IS A JR.-MID LEVEL ROLE 10-15% TRAVEL BETWEEN MULTIPLE SITES EXPOSURE TO SYSTEM VALIDATIONS WITHIN LAB AND MFG PHARMA ENVIRONMENTS SOLID UNDERSTANDING OF GMP ENVIRONMENT REQUIREMENTS. NO ENTERPRISE IT VALIDATION CANDIDATES. The role requires assisting in computer system validation efforts, supporting quality system governance, and ensuring all work is carried out in compliance with cGMPs, company policies and procedures, 21 CFR Part 11, EU Annex 11, ICH guidelines, and other applicable industry regulations. Responsibilities may include:...

View CSV Specialist Job - Durham, NC 27710
Sr. Manager, Regulatory Affairs
Science & Biotech - Morrisville, NC 27710

Overall responsibility for the management of US Regulatory Affairs matters and maintenance of NDAs relating to the approved pharmaceutical products portfolio, in support of the business goals. This includes: • Review and approval of promotional materials in accordance with labelling including oversight of filing of 2253s • Review and approval of packaging materials in accordance with labelling, and approval of artwork through partner electronic portal • Maintenance of NDAs including coordinating compilation and submission of ad hoc reports, aggreg...

View Sr. Manager, Regulatory Affairs Job - Morrisville, NC 27710
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
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
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
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.
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
Medical Director, Medical Affairs Ophthalmology
Science & Biotech - Bedminster, NJ 07921

Our client, a growing pharmaceutical company preparing for another exciting launch, is currently looking for a Medical Director, Medical Affairs for their growing team. This position can be based in Irvine, CA or in the Bedminster, NJ area. Responsible to work in close collaboration with the V.P. Medical 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 ...

View Medical 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