Principal Biostatistician - Clinical Trials - Remote Eligible

Rockville , MD
Sep 07, 2021
Oct 01, 2021
Full Time
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 has a new opportunity in its Clinical Trials Practice (CTP) for a Principal Biostatistician to lead and support Phase 1- 4 clinical trial studies across a variety of therapeutic areas, including oncology and infectious diseases. In this senior role, which can be based remotely, you will function as a lead statistician in studies, collaborate with sponsors, and be responsible for representing all statistical aspects of the study in regulatory interactions. Your effective communication skills will be key, as well as your ability to work in a matrix environment and with multiple projects. 

Job Responsibilities:
  • Lead, support, and collaborate with sponsors and other Westat staff on the development of:
    • Study 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 forms and database requirements.
    • Data and statistical deliverables.
    • 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)
  • Guide/mentor junior clinical trial statisticians.
  • Oversee study-specific clinical trial statistical and programming requirements 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. 
    • Produce and validate Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE).
  • Collaborate with the clinical SAS programming team to develop SAS macro libraries to standardize routine analysis or to implement new methods. 
  • Contribute to development and maintenance of functional-level standards, SOPs, and templates, and maintain standards for clinical trial statistical activities.
  • Collaborate with CTP staff and other Westat departments on business development activities.
  • Represent Westat Clinical Trials Practice in external environments including professional conferences and workshops.

Basic Qualifications:
  • A Master's degree in Statistics or related field with at least 8 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 about design and analysis issues and strong understanding of FDA and ICH regulatory guidelines.

Preferred Qualifications:
  • A Doctoral degree in Statistics or related field.
  • Knowledge and experience in the application of Bayesian analysis and development of adaptive trial designs.


Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Eligible employees may participate in:
  • Employee Stock Ownership Plan
  • 401(k) Retirement Plan
  • Paid Parental Leave
  • Vacation Leave
  • Sick Leave
  • Holiday Leave
  • Professional Development
  • Health Advocate
  • Employee Assistance Program
  • Travel Accident Insurance
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Short Term Disability Insurance
  • Long Term Disability Insurance
  • Life and AD&D Insurance
  • Critical Illness Insurance
  • Supplemental Life Insurance
  • Flexible Spending Account
  • Health Savings Account


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.