Principal Statistician

Position Summary:
Principal Statisticians provide statistical expertise to the design and interpretation of clinical studies and clinical development programs under the guidance of more senior staff. They provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work. They engage in analyses to exploit information to improve design and decision-making. They support the Global Product Statistician (GPS) in providing statistical support to the clinical trial team (CTT), the clinical sub-team (CST) and Product Development Team (PDT). They take on responsibility for components of regulatory submissions including specification and construction of overview documents and responses to regulatory questions. Principal Statisticians may also contribute to/ or lead process improvement or a capability area within the Department.
Major Duties and Responsibilities (including supervising others):

* Provide statistical expertise under the guidance of more senior staff
* Serve as primary author for statistical sections of protocols
* Perform statistical analyses and create statistical text for clinical publications and other communications
* Provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work, holding partners/providers accountable for the quality of their deliverables
* Engage in analyses to exploit information to improve design and decision-making
* Support the GPS on the development of Target Product Profile and Target Product Claims (TPP/TPC), Benefit, Risk, Value and Uncertainty (BRV(U)), clinical development plan (CDP), and regulatory strategy
* Take on responsibility for components of regulatory submissions
* May participate in interactions with Health Authorities.
* May also contribute to/or lead the development of a process improvement and/or capability area within the Department
* May also participate in providing statistical support/strategy for post-marketing/Medical Scientific Affairs activities