The Clinical Research Biostatistician will perform a dual role as a statistical resource to study teams and clients and as a statistical manager.
As a statistical resource, this individual will contribute to the design of clinical research studies (e.g. refining research questions, performing sample size calculations, and writing statistical analysis plans); review table/listing/figure (TLF) shells prepared by junior staff; review analysis data set and TLF specifications; conduct advanced-level analyses; and make substantive contributions to clinical study reports and manuscripts. This position will also interact with other study team members and clients on study set up (including randomization) and serve as Independent Statistician to Data and Safety Monitoring Boards (DSMBs).
As a statistical manager, contribute technical pieces to proposals, coordinate the provision of statistical services, and manage related aspects of study timelines and budgets. Work with division Director to ensure the availability of statistical resources on projects; keep study teams informed of unanticipated challenges; oversee the work of junior statistical staff; and manage client relations with respect to statistical needs of studies.
Experience with CDISC standards for eCTD submissions required. Prior working experience within a Clinical Research Organization [CRO], working with clinical studies conducted in developing countries and vaccine-related trials preferred.
- Inform the design of clinical studies
- Provide technical oversight to statisticians and programmers implementing research studies.
- Carry out advanced level statistical analysis.
- Write statistical sections of study reports; review reports and manuscripts for accuracy of reporting and inference.
- Contribute to proposal development.
- Manage the accurate and timely delivery of statistical services on a portfolio of related studies.
- Serve as Independent Statistician to DSMB on more complex analyses (e.g. those involving stopping rules).
- Stay current on relevant research and statistical methodologies via statistical training, self-study, internal training and courses, external conferences and courses, etc.
Problem Solving & Impact:
- Problems are varied and complex, requiring analysis or interpretation of factors or situations. Anticipates problems, proactively works to avoid them. Proposes and may lead new initiatives.
Supervision Given/Received:
- Reports to Divisional Director or Principle Biostatistician
- Independently manages high volume work load.
- Able to function independently as lead statistician
- Solid understanding of scientific and ethical principles and industry best practices in biomedical research analysis
- Increased breadth or depth of statistical knowledge, such as: working knowledge of more complex methods, wider range of therapeutic areas; or analysis methods for a broader range of study designs
- Ability to communicate and interact effectively with non-statistical colleagues on project teams
- Excellent interpersonal communications skills (verbal & written) in English
- Typically requires 7+ years of research experience.
- Demonstrated expertise and leadership in statistical analysis of clinical or other biomedical studies of drugs, biologics, and/or devices submitted to stringent regulatory authorities
- Advance skills in multiple statistical areas.
- Excellent interpersonal communication skills, verbal and written English.
- Advance experience providing statistical consultation to researchers.
Travel Requirements:
- Less than 10%