- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking an experienced Biostatistician to join our Biometrics organization for a long-term contract position.
Responsibilities (include but are not limited to):
- Provides statistical expertise and input to drug development programs, including the reporting of study results, specification and generation of tables, listings, and figures, and analyses requiring advanced statistical methodologies.
- Works closely with senior statisticians and programmers to deliver pre-planned and ad-hoc analyses
- Works closely clinical development and translational research and clinical development to write study protocols and design experiments and analyze and interpret data
- Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis data-sets, 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 work with data management and programming to identify data issues and build standards for databases, edit checks, and statistical programming for data analyses.
- Establishes and maintains effective working relationships with 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
- 3+ 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
- Working knowledge of SAS