Director, Medical Affairs Statistical Sciences

Position Overview :

A leading life sciences company is seeking a Director of Statistical Sciences within Medical Affairs to provide technical leadership and strategic oversight in post-approval clinical research, disease registries, and real-world evidence (RWE) studies. This role will collaborate with internal teams, including medical affairs, market access, and health economics, to support publication initiatives and data-driven decision-making. Additionally, the Director will engage with regulatory agencies regarding clinical data submissions and statistical methodologies.

Location : Remote or hybrid, with a preference for candidates based in the West Coast, U.S.

Key Responsibilities :

• Oversee statistical deliverables for post-approval studies, registries, meta-analyses, publications, and scientific presentations.
• Ensure statistical integrity, accuracy, and compliance with regulatory requirements.
• Provide statistical guidance on study design, endpoint selection, and sample size assessments.
• Develop statistical analysis plans (SAPs) and interpret findings for key stakeholders.
• Lead statistical modeling strategies for real-world data and natural history studies.
• Collaborate cross-functionally with medical affairs, market access, and regulatory teams.
• Support vendor selection, management, and oversight of outsourced statistical activities.
• Present research findings at external conferences and contribute to publications.

Qualifications & Skills :