Director or Associate Director of Biostatistics
Located in Cambridge, MA!
- Responsible for the delivery, integrity, and quality of clinical data across the company portfolio.
- Grows and develops a Biometrics team consisting of both internal and vendor contributors, including biostatistics, programming, and data management functions, that is scalable and right sized to the organization’s needs.
- Leads programming and statistical activities with hands on approach and provides oversight of external vendors to ensure timelines and quality of analysis data and statistical output; reviews and approves key data management and statistical vendor deliverables; plans and directs study level analysis, providing guidance to statistical programmers on SDTM/ADaM and TLF specifications development and programming.
- Serves as the statistical leader in the design, analysis, and interpretation of clinical study data and in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report and other regulatory submission documents or publications, ensuring accuracy and statistical validity.
- Explains statistical concepts in an easy understandable way to non-statisticians and provides adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required; interprets and translates computational results into biologically relevant conclusions and hypotheses; discusses biological questions, problems, and outcomes.
- Performs as core member of the Clinical Development Team and advises team on most up-to-date statistical methodology and tools in oncology drug development.
- Provides input to database requirements and works closely with data management and clinical science functions to ensure data quality standards are met.
- Leads technology-based initiatives to support clinical development with data visualization tools or other technologies.
- Develops strong and collaborative working relationships with key business stakeholders (e.g. Project Team leaders, Asset Team Leaders, functional heads within Clinical Development, Research and others).
- Mentor’s direct reports to maximize their potential.
- Ph D. or M.S. in statistics or biostatistics preferred with experience in the pharmaceutical or biotechnology industry.
- Oncology experience required.
- Management experience with proven capability as a successful leader in a strategic, cross-functional environment.
- Extensive knowledge of clinical trial development and statistical methodology related to trial design and conduct of clinical studies is required.
- Strong knowledge of ICH, FDA, and GCP regulations and guidelines.
- Strong well-rounded technical skills with SAS, CDISC/SDTM, and Adam data models.
- Scientific background and understanding of clinical trials, clinical development operations and regulatory compliance.
- Extensive experience negotiating successfully with health authorities.
- Strong business acumen and critical thinking skills.
- Flexible, well organized, comfortable with ambiguity and works well under pressure.