Senior Clinical Trials Biostatistician

Westat Rockville , MD 20850

Posted 2 months ago

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 Statistician to lead and support Phase 1- 4 clinical trials across a variety of therapeutic areas. The Sr. CT Statistician 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.

Candidates must possess:

  • 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.

Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the position, based on the specific position which may include, for example, identity verification, employment history, or criminal records history.

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 any other protected status under applicable law.

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Senior Clinical Trials Biostatistician