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Sr. Statistical Programmer (8-10 years) REMOTE
Science & Biotech - remote, NJ 07101

Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Create all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE Work with all types of safety data and ...

View Sr. Statistical Programmer (8-10 years) REMOTE Job - remote, NJ 07101
statistical programmer, SAS programmer, SDTM, CDSIC, SAS, Masters, Bachelors, ADaM,
TrackWise Administrator
Science & Biotech - Philadelphia, PA 19355

Trackwise Administrator Location: suburban Philadelphia area Support TrackWise •Perform business requirements gathering, requirements analysis, business system design, installation, configuration, user testing and validation support of TrackWise based applications •Lead and drive value-added TrackWise expansion into applicable areas and departments •Perform report customization using Crystal Reports for TrackWise and other reporting tools •Troubleshoot problems with existing configurations, master data selection lists, interfaces and reports ...

View TrackWise Administrator Job - Philadelphia, PA 19355
TrackWise, 21CRF Part 11
Remote Contract- Sr. Biostatistician
Science & Biotech - Remote, NC 28201

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data ...

View Remote Contract- Sr. Biostatistician Job - Remote, NC 28201
Biostatistician, Statistician, Principal Statistician, Principal Biostatistician, Lead Biostatistician, Clinical Statistician, Data Analyst
Remote Contract- Sr. Biostatistician
Science & Biotech - REMOTE, GA 30327

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data ...

View Remote Contract- Sr. Biostatistician Job - REMOTE, GA 30327
Biostatistician, Statistician, Principal Statistician, Principal Biostatistician, Lead Biostatistician, Clinical Statistician, Data Analyst
Remote Contract- Sr. Biostatistician
Science & Biotech - REMOTE, CA 94123

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data ...

View Remote Contract- Sr. Biostatistician Job - REMOTE, CA 94123
Biostatistician, Statistician, Principal Statistician, Principal Biostatistician, Lead Biostatistician, Clinical Statistician, Data Analyst
Senior Site Manager - Toronto, Canada
Science & Biotech - Toronto, ON M4B 1B3

DOCS Global is the premier resource provider in the biopharmaceutical and medical device industries. We currently have an exciting opportunity available in Toronto, Canada. The Senior Site Manager serves as primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through ...

View Senior Site Manager - Toronto, Canada Job - Toronto, ON M4B 1B3
clinical research associate, CRA, Senior Clinical Research Associate, SCRA, monitoring, CRO
Clinical Trial Assistant
Science & Biotech - Arden Hills , MN 55112

Acts as an in-house Clinical Research Associate providing support to clinical functions and site customers through site start up, enrollment, follow up and closure phases of clinical trial activities. Key Responsibilities: Site Start-Up: works across several studies to ensure all required documentation is in place in order 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 repor...

View Clinical Trial Assistant Job - Arden Hills , MN 55112
Associate 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 Associate Director - Clinical Trial Operations Job - South San Francisco , CA 94080
Clinical Geneticist
Science & Biotech - Rye, NY 10528

Clinical MEDICAL GENETICIST JOB OPENING IN WESTCHESTER COUNTY NY (30 minutes North of NYC) An exciting opportunity to join an established Comprehensive Medical Genetics practice serving in NYS. We are seeking a full-time tenure track Biochemical/Clinical Geneticist to join our Inherited Metabolic Disease Center and Clinical Genetics Practice. We are a Newborn Screening Referral Center and also have an active Lysosomal Storage Disease Center managing a large cohort of patients. Our physicians are part of a network which have academic appointme...

View Clinical Geneticist Job - Rye, NY 10528
molecular, pathology, NGS, technologist, genetics, ASCP, MB, abmg, director, MD, PhD, geneticist, cytogenetics
Pharmaceutical Clinical Outsourcing & Vendor Contracts Manager
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 Manager Job - Boston, MA 02111
Clinical Trial Agreements, Contracts, Agreements, Budgets, Pharmaceutical, Clinical Research, GCP, Negotiation, Outsourcing, Vendors
Sr. Manager, GCP Clinical and Regulatory Quality Management
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 Clinical and Regulatory Quality Management Job - New York, NY 10017
GCP, Good Clinical Practices, QA, Quality Assurance, Auditor, Clinical Research, Clinical Trials, ICH, Pharmaceutical, SOP's
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
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
Director, Clinical Scientist
Science & Biotech - Raleigh, NC 27709

Our client, a growing Oncology Biotech company in the RTP area, is currently hiring a Director, Clinical Scientist and expanding their 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 ...

View Director, Clinical Scientist Job - Raleigh, NC 27709
clinical scientist, regulatory submissions, medical writer, protocol author
Medical Science Liaison - Ophthalmology - South Central Region
Science & Biotech - Nashville, TN 37115

Our client, a growing global pharmaceutical company, is currently seeking qualified candidates for full-time positions in their Medical Affairs department for their South Central region. The successful candidates will have a Doctorate degree (MD, OD, PharmD, PhD,) with 2 - 8 years of experience required as an MSL in the pharmaceutical industry. Experience in Ophthalmology is required. The Medical Science Liaison (MSL) will be responsible for engaging and developing relationships with national and regional Medical Experts (MEs) within their geogr...

View Medical Science Liaison - Ophthalmology - South Central Region Job - Nashville, TN 37115
MSL, ophthalmology, travel, glaucoma, retina, pharmaceutical
Medical Science Liaison - Ophthalmology - South Central Region
Science & Biotech - Dallas, TX 75201

Our client, a growing global pharmaceutical company, is currently seeking qualified candidates for full-time positions in their Medical Affairs department located in the South Central region. The successful candidates will have a Doctorate degree (MD, OD, PharmD, PhD,) with 2 - 8 years of experience required as an MSL in the pharmaceutical industry. Experience in Ophthalmology is required. The Medical Science Liaison (MSL) will be responsible for engaging and developing relationships with national and regional Medical Experts (MEs) within their ...

View Medical Science Liaison - Ophthalmology - South Central Region Job - Dallas, TX 75201
MSL, ophthalmology, travel, glaucoma, retina, pharmaceutical
Principal Engineer, Delivery Systems
Science & Biotech - Durham , NC 27703

Job Title: Principal Engineer, Delivery Systems Our client, a growing global pharmaceutical company, is seeking qualified candidates for a full-time Principal Engineer, Delivery Systems Development position in R&D, Implant Manufacturing division located in Durham, NC. This position will be responsible for driving the development and manufacture of implant delivery devices used for their extended-release, sterile, ophthalmic products from early pre-clinical development through phase 3 clinical studies. Essential Duties & Responsibilities: T...

View Principal Engineer, Delivery Systems Job - Durham , NC 27703
engineer, device, pharmaceutical, manufacturing, RTP
Sr. Statistical Programmer- Boston, MA
Science & Biotech - Boston , MA 02111

Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Create all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE Work with all types of safety data and ...

View Sr. Statistical Programmer- Boston, MA Job - Boston , MA 02111
Sr. Statistical Programmer, Senior Statistical Programmer, SDTM, ADaM, CDISC, CFR, FDA, SAS, Biotechnology, mathematics, computer science, BS, Bachelors Degree,
Sr. Statistical Programmer- REMOTE
Science & Biotech - san diego, CA 92122

- 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 - san diego, CA 92122
SAS, OMOP, Bachelor's Degree, Sr. Study Programmer, epidemiology, Hadoop, medical claim, medicare, EMR, Medicaid, healthcare , SQL
Grants Analyst
Science & Biotech - Princeton, NJ 08648

DOCS Global is hiring! We are THE premier resource provider in the biopharmaceutical and medical device industry. Join our team as a Grants Analyst and realize your career growth opportunities. Specs: • Manage relationships with vendors to ensure all invoices are received and paid in accordance with the terms of corresponding Contracts or Statements of Work • Manage responses to internal and external stakeholder inquiries regarding invoicing, contracts, reconciliations, aging reports, and other special requests. • Ensure the optimum financial...

View Grants Analyst Job - Princeton, NJ 08648
Biostatistician -REMOTE
Science & Biotech - remote , CA 92122

- Onsite preference San Diego or remote - 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operation...

View Biostatistician -REMOTE Job - remote , CA 92122
biostatistician, sr. biostatistician, statistician, sr. statistician, SAS, PhD, manager
Director, Analytical Development
Science & Biotech - Durham, NC 27703

The purpose of the Director of Analytical Development is to provide the planning, development, qualification and execution of analytical assays to support internal Research & Development, Process Development and recombinant vector manufacturing. The successful candidate will have a Master’s or PhD degree in Bioanalytical Chemistry, Chemistry, Biology, Biochemistry, Virology or related field and have a working knowledge of qPCR, ELISA, SDS-PAGE/Western blot, HPLC, RP-HPLC, HPLC-SEC and cell based potency assays etc. This individual will lead an analy...

View Director, Analytical Development Job - Durham, NC 27703
Biostatistician
Science & Biotech - Berkely, NJ 07922

- 9 month potentially renewable contract - Onsite NJ CORE JOB FUNCTIONS: • Responsibilities will include analysis of clinical trial data with emphasis on translational data in addition to analysis of clinical, quality of life and of real world data. • Work under the direction of Medical Affairs Statistics Disease Lead. • Actively provide statistical support in the Medical Affairs Department, with emphasis on support of translational research. • Actively provide statistical support to the Medical Affairs Department. • This position coul...

View Biostatistician Job - Berkely, NJ 07922
biostatistician, sr. biostatistician, statistician, sr. statistician, SAS, PhD, MS, manager
Senior Director Medical Affairs
Science & Biotech - Rockville, MD 20850

Senior Director, Medical Affairs The Head/Sr. Director of Medical Affairs provides overall strategic and operational medical and scientific leadership for all medical affairs activities. It includes building and leading a best-in-class Medical Affairs organization and supporting the development and, ultimately, the commercialization of all pipeline products. The initial focus will be in the U.S. and Europe supporting development with a global scope of responsibility for the overall portfolio with a focus on increasing awareness externally for ...

View Senior Director Medical Affairs Job - Rockville, MD 20850
Medical Affairs
Director/Senior Director of Clinical Development Ophthalmology
Science & Biotech - Rockville, MD 20850

Reporting to the Vice President of Clinical Development, the Clinical Development Lead will be responsible for providing innovative scientific knowledge, skill, and technical expertise for assigned clinical programs, and projects. This position is responsible for the development of gene therapy products to treat neovascular (wet) age-related macular degeneration. We utilizes a cross-functional product development team approach to effectively support the initiation, development and registration of candidate drugs. The Senior Director Clinical Research ...

View Director/Senior Director of Clinical Development Ophthalmology Job - Rockville, MD 20850
ophthalmology AND clinical development
Clinical Programmer
Science & Biotech - Summit, NJ 07901

- 1 year renewable contract - Onsite NJ Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with standards Lead collaborative cross-functional team study build meetings for in-house and outsourced studies Review edit checks for in-house and outsourced studies Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and standards Participate in and lead team meetings when appropriate Act as primary CRO contact, when ne...

View Clinical Programmer Job - Summit, NJ 07901
clinical programmer, CRO, data management, FDA
SAS Programmer - Remote!
Science & Biotech - Durham, NC 27703

5+ years' experience as a CRO SAS Programmer CDISC experience (SDTM, ADaM, Define.xml) Experience leading multiple studies across multiple TAs. Experience with Sponsor interaction and bid process activities Experience leading a project team Conduct QC/Validation of SAS code Expertise in SAS language options including Macro language, BASE SAS, SAS/STAT and SAS/GRAPH BS/MS Math, Statistics, Computer Science, or related field

View SAS Programmer - Remote! Job - Durham, NC 27703
Project Manager R&D
Science & Biotech - Durham, NC 27703

This PM role will focus on Specialty R&D development projects in North Carolina and PM support for Specialty R&D development projects in India. Role responsibilities include components of: resource management, financial management, quality management, risk management, control management and business continuity management. DUTIES & ESSENTIAL JOB FUNCTIONS Help define the project charter, roles, tasks, milestones, budgets and measures of success to support the business case. Develop project estimates and plans to manage end-to-end project execu...

View Project Manager R&D Job - Durham, NC 27703
Sr. Statistical Programmer- ONSITE SAN FRANCISCO
Science & Biotech - San Francisco, CA 94080

Develop and maintain datasets as per the CDISC (SDTM and ADaM) standards; Extract data from various databases; Develop and maintain programs to analyze the data and produce reports consisting of Tables, Listings and Graphs that are generated from the available databases; Apply Programming Development Life Cycle (PDLC) principles; Develop programs using SAS(Statistical Analysis Software) and SQL; Perform Programming using SAS software analyzing the clinical trial data to produce the outputs for the clinical trial report; Prepare specifications an...

View Sr. Statistical Programmer- ONSITE SAN FRANCISCO Job - San Francisco, CA 94080
Sr. Statistical Programmer, Senior Statistical Programmer, SDTM, ADaM, CDISC, CFR, FDA, SAS, Biotechnology, mathematics, computer science, BS, Bachelors Degree,
Entry Level Medical Writer
Science & Biotech - Durham, NC 27709

The R2 Medical Writer will prepare trial disclosure documents in compliance with trial transparency laws and requirements and client policies. • Clinical trial registration and results posting on www.ClinicalTrials.gov. • Coordinating quality assurance reviews of documents and maintain audit trails of changes. • Prepares scientifically valid draft and final narratives for posting to www.ClinicalTrials.gov, inclusive of the scientific interpretation of data, and the writing of clinical, pharmacokinetic and pharmacodynamic results for studies o...

View Entry Level Medical Writer Job - Durham, NC 27709
Director-Senior Director of Clinical Operations
Science & Biotech - Lexington, MA 02421

The Sr. Director/Director, Clinical Operations is a member of the Clinical Operations Department. The Clinical Operations department is responsible for the management (planning, implementation, maintenance and close out) of the Clinical trials with a focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety. There are approximately 10 employees in the department with some of the activities outsourced to Clinical Research Organizations. The Sr. Director/Director, Clinical Operations will lea...

View Director-Senior Director of Clinical Operations Job - Lexington, MA 02421
clinical trial operations, project management
Lead Clinical Data Manager - REMOTE!
Science & Biotech - Durham, NC 27707

The selected candidate will serve as the technical leader on all data management aspects for project(s) including start-up,maintenance, and completion activities and develop [Global]Data Management Plans and Quality Management (QM) plans that will deliver accurate, timely, consistent, and quality clinical data. Additional responsibilities include: • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and + Coordinate and participate in the development ...

View Lead Clinical Data Manager - REMOTE! Job - Durham, NC 27707
QA Manager (GMP)
Science & Biotech - Durham, NC 27707

REPORTING RELATIONSHIPS Direct reports: up to 5 DUTIES & ESSENTIAL JOB FUNCTIONS Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems Establishing and maintaining Site SOPs in collaboration with Mfg. staff Create and maintain Site Master Validation Plan Review of Batch Records and approve product disposition Review of analytical, stability test methods, protocols & reports Release of raw materials, components, in-process materials and finished products Review and approve investigation reports as appl...

View QA Manager (GMP) Job - Durham, NC 27707
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
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
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
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
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
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.
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 - Research 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 - Research 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
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