Principal Biostatistician - Remote - Clinical Trials

Rockville , MD
Jan 15, 2022
Feb 08, 2022
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's Clinical Trials Practice (CTP) is a full-service Clinical Research Organization (CRO), which provides service to both government and academic institutions as well as to commercial clients. Westat has a new opportunity in its CTP for an experienced biostatistician to lead the design, analysis, and reporting of various biomedical research projects including Phase 1- 4 randomized clinical trials across a variety of therapeutic areas, including oncology, infectious diseases, and complementary health interventions. In this role, which can be remote, you will function as a subject matter expert statistician for clinical research studies and will collaborate with sponsors. Your effective communication skills will be key, as well as your ability to work in a matrix environment and on multiple projects. 

Job Responsibilities:
  • Lead, support, and collaborate with sponsors and other Westat staff on the development and review 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, figures, and listings, 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).
  • 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, figures, and listings) 
    • SAS programs and CDISC data sets are validated and analyses are performed as specified in study 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.

Basic Qualifications:
  • A Doctoral degree in Biostatistics or related quantitative field.
  • At least 10 years of relevant professional experience including 5 or more years of hands-on experience in the design, analysis, interpretation, and reporting of clinical trials.
  • Experienced in programming and use of statistical software (primarily SAS and R) including planning and conducting computer simulations.

Preferred Qualifications:
A broad and deep understanding of:
  • the scientific methodology including strengths and weaknesses of different study designs and impacts of measurement errors
  • optimal choice of primary and secondary study endpoints
  • adequate justification of sample sizes, Type I and II errors, and study power
  • appropriateness of different statistical methodology and techniques to match research objectives and hypotheses for different variable types
  • study design types (including fixed and adaptive), alpha spending, and multiplicity control
  • ability to interpret and defend study results in submissions to peer-reviewed publications and regulatory agencies and in communications with non-statistician audiences
  • published in peer-reviewed scientific literature (statistical and other biomedical journals), experienced in presenting to professional and academic audiences, and experienced in writing and evaluating research proposals and/or peer-reviewed manuscripts.

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


Protecting the health and safety of our employees and survey participants is a top priority for Westat. As a federal government contractor, Westat will require Westat staff, regardless of work location, to provide proof that they are fully vaccinated against COVID-19 upon hire and to follow all safety protocols, subject to approved accommodations under applicable law.

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.

Similar jobs