Senior Manager, Biostatistics - United States
- Our company is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells.
- Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.
- We are seeking a highly motivated individual to join us as a Senior Manager, Bio statistics.
- You will work with the Bio statistics team in supporting our efforts in this exciting new area of cancer immunotherapy.
- This role will be a hands-on resource reporting to the Sr. Director, Bio statistics.
- The senior manager, Bio statistics will be responsible for all statistical aspects within a clinical development program, including statistical input into the clinical development plan, support of translational research, design and analysis of clinical trials, interaction with regulatory authorities and key opinion leaders, and management and oversight of outsourcing partners, with a particular emphasis on safety reporting and pharmacovigilance.
- The senior manager, Biostatistics will be accountable for the validity and quality of all statistical input and deliverables for the assigned projects.
- Additionally, the senior manager, Biostatistics will provide consultancy to other project teams within research and development, regulatory affairs, manufacturing, and quality.
- Provides statistical expertise and input to drug development programs and safety surveillance including the design of clinical development plans, studies, and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may affect the statistical integrity of the development program or for which statistical tools may add value.
- Provides statistical input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.
- Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Authors technical reports and publications, ensures the timely delivery of top line study results.
- Ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses.
- Ability and experience to work with safety to develop appropriate tools and analysis strategies for safety surveillance
- Monitors project progress and ensures proper resource allocation; performs vendor oversight for assigned programs and provides quality review of vendor deliverables.
- Establishes and maintains effective working relationships with vendors and project teams.
- Knowledge of advanced clinical trial design concepts and an understanding of clinical / regulatory concepts in oncology; maintains currency with developments in these fields.
- Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
- MS or PhD in biostatistics, statistics, or mathematics
- 6+ years experience in biostatistics in clinical development and drug development experience in oncology
- Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to drug development
- Excellent verbal, written, and presentation skills including the ability to clearly describe advanced statistical techniques and interpret results
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.