Penfield Search Partners
Contact: Mark Maurer – email@example.com
Job Description: The Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and expertise for a product line through the entire development process. This role provides statistical input into the drug development plan, researches and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This role is also a key member of the clinical development program team and collaborates cross functionally with Clinical Science, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and other teams. This role also may present statistical topics to senior management or external partners as needed.
The position can be based remote, with occasional visits to NJ HQ as needed.
- Additional representative responsibilities will include, but not necessarily be limited to, the following:
- Identify, justify, and optimize statistical strategies for responsible clinical development programs, regulatory submissions, and regulatory interactions.
- Collaborate with Clinical Sciences to optimize the study design and contribute to drug development plans.
- Contribute to documents submitted to global Health Authorities. Represent Biostatistics at meetings with regulatory authorities.
- Develop statistical analysis plans to ensure the accordance with regulatory guidelines.
- Lead statistical activities including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review.
- Manage the timelines and oversee the quality of statistical analyses by CRO or internal programming teams
- Provide input to study team on all aspects of statistical activities. Collaborate with data manager to ensure high quality data collected.
- Effectively communicate on statistical topics within and outside of the clinical program teams.
- Enrich statistical and regulatory knowledge. Explore advanced statistical methodologies for the benefit of business.
- Lead and contribute to departmental projects.
- Mentor less experienced statisticians.
- Masters’ degree in Statistics or Biostatistics with a minimum of 12 years of clinical trial experience in a biotech, pharmaceutical, or CRO setting; or PhD with a minimum of 10 years’ experience.
- Experience in regulatory submissions and regulatory interactions over required tenure a must.
- Strong knowledge of statistical methodologies applicable to Clinical Research.
- Strong knowledge of clinical research and medical terminology for study design and results interpretation.
- Knowledge of statistical ethics, guidelines, and principals established by US Food and Drug Administration (FDA), European Medicines Agency (EMA), International Conference on Harmonisation (ICH), and the American Statistical Association.
- Good programming skills in SAS and working knowledge of software such as nQuery, R, etc.
- Strong analytical and problem-solving skills.
- Excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Able to identify and investigate causality independently and formulate potential solutions.
- Able to prioritize multiple tasks, manage vendors in completing the deliverables with high quality according to timelines, and provide recommendations to improve process.
- Able to operate independently and make key business decisions.
- Thinks strategically and plans for future business need on assigned product line.