Associate Director Biostatistics
Location: DMV Area - DC, Maryland, and Virginia Tri-State Area
Salary: $170,000 - $200,000 + bonus + excellent benefits
A leader in the discovery and development of innovative oncology medicines is looking for an Associate Director Biostatistics to grow their rapidly growing team. This company has a product on the market and a strong pipeline of product candidates to treat various autoimmune disorders and infectious diseases in addition to cancer treatments, and they partner with leading global pharmaceutical companies.
The Associate Director Biostatistics will provide statistical leadership and spearhead strategic discussions on the planning of clinical development of molecules. They will oversee the biostatistics aspects of trial design and provide leadership on multiple clinical studies/compounds. The team is looking for a strong communicator with innovative critical thinking skills that can use their experience in leading efforts to collaborative with cross functional teams.
Responsibilities:
- Serve as lead biostatistician on multiple clinical studies/compounds
- Write and review statistical sections of protocols, statistical analysis plans, statistical programming plans, clinical study reports, etc.
- Performing statistical design, simulation, and analysis of clinical studies
- Cross-functionally collaborates with both Data Management on the development and review of CRFs, data cleaning, and database design, as well as Statistical Programming on the development of data outputs (TLF shells)
- Contributes to the preparation of regulatory documents (meeting request, briefing documents, etc),
- Responsible for the statistical aspect of regulatory submission (ISS, ISE, IND, BLA, etc)
- Represents biostatistics in regulatory interactions
- Assist in the technical growth of junior biostatisticians
Requirements:
- Masters or Ph.D in statistics or related field
- Biostatistics experience with clinical trials, oncology preferred
- 8+ years of directly related experience in the pharmaceutical, biotechnology, medical device, or CRO industry
- Strong statistical knowledge and technical skills as related to clinical trial designs, simulations, and analyses
- Demonstrated understanding of regulatory guidance on clinical trials, endpoints, and issues
- Seasoned experience in SAS and other relevant software for trial design, simulation, and analysis
