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Senior Clinical Trial Biostatistician (Virtual/Remote)

Company: Westat
Location: Rockville
Posted on: November 19, 2020

Job Description:

Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC. Westat is seeking a Senior Clinical Trial Biostatistician to lead and support Phase 1- 4 clinical trials across a variety of therapeutic areas. In this role you will collaborate with clients and sponsors, and manage, oversee, and expand capabilities of CT statistical staff. Job Responsibilities: - Lead, support, and collaborate with clients and other Westat staff on the development of: -- Protocols, which includes the selection of appropriate trial designs and statistical methodology, study endpoints, sample sizes, and statistical sections of the protocol; -- Statistical analysis plans and mock tables, listings and figures, as well as SAS programming and edit specifications. -- Case report form and database requirements; -- Data and statistical deliverables; and -- Regulatory documents containing statistical information and clinical data (e.g. IRB Reports, DMC Reports, Clinical Study Reports, INDs, IDEs, NDAs, BLAs, 510(k)s, PMAs). - Manage the Clinical Statistics Team and guide/mentor junior clinical trial statisticians. - Manage and oversee clinical trial statistical and programming staff to ensure: --Appropriate SAS programs and specifications are developed to generate regulatory compliant deliverables (e.g., SDTM and ADaM data sets/analysis files, and tables, listings, and figures). -- SAS programs and CDISC data sets are validated. -- Analyses are performed as specified in protocols and statistical analysis plans. -- Data and statistical deliverables comply with regulatory authority requirements and guidelines. -- Develop and maintain functional-level standards, SOPs, and templates, as needed, and maintain standards for clinical trial statistical activities. -- Collaborate with the clinical SAS programming team to develop SAS macro libraries to standardize routine analysis or implement new methods. Produce and validate Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE). -- Collaborate with CTA staff and other Westat departments with business development activities. Basic Qualifications:-- -- A Master's degree in Statistics or related field with at least 7 years of relevant experience supporting clinical trials in the Pharmaceutical, Biotechnology or CRO industry. OR -- A Doctoral degree in Statistics or related field with at least 5 years of relevant experience supporting clinical trials in the Pharmaceutical, Biotechnology or CRO industry. -- Extensive knowledge of Pharmaceutical Statistics and Medical Statistics. -- Prior experience interacting with FDA staff regarding design and analysis issues and strong understanding of FDA and ICH regulatory guidelines. Preferred Qualifications: -- Strong organizational skills and excellent written and oral communication skills. -- Knowledge of Bayesian analysis and adaptive trial design a plus but not required Westat offers competitive benefits with ESOP, 401k, Health, Dental, paid vacation, sick and holiday leave, professional development as well as other benefits. Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law.

Keywords: Westat, Rockville , Senior Clinical Trial Biostatistician (Virtual/Remote), Other , Rockville, Maryland

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