What are the responsibilities and job description for the Director, Medical Affairs, Statistical Sciences position at BioTalent Ltd?
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 :
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