A Connecticut-based pharma company is actively seeking a new remote Biostatistician to join their growing team. In this role, the Biostatistician will be responsible for participating in developing plans for client’s clinical developments by using expertise in statistics, design and analysis of clinical trials, and data analytics and mining through cross-functional collaboration and decision-making process.
Responsibilities:
- Provide statistical expertise into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives
- Collaborate effectively cross-functionally (e.g., with clinical research, regulatory strategy, data management, statistical programming, medical writing, etc.) to facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, and serve as internal statistical expert in the overall program
- Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making
Qualifications:
- 7+ years of related experience in Clinical Development
- Master’s Degree and/or Ph.D. in Biostatistics, Mathematics, Statistics, and/or a related field
- Proficiency in Statistical Programming languages/software such as SAS, R, etc.
- Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides and 21 CFR Part 11
- Familiarity with EMA/CHMP regulations and guidelines
- In-depth knowledge of the Global Drug Development process
- Solid analytical and problem-solving skills
Desired Skills:
- Prior experience working with Oncology studies (solid Tumor or Hematologic malignancies)
- NDA/BLA submission experience
