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Director, Medical Affairs, Statistical Sciences
Job description
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:
- Advanced degree (MS/PhD) in Statistics, Biostatistics, or related field.
- 10+ years of experience in statistical sciences within the pharmaceutical, biotech, or CRO industry.
- Expertise in causal inference models, real-world evidence (RWE), and HEOR methodologies.
- Strong experience supporting clinical trials and regulatory interactions.
- Proficiency in R and/or SAS for statistical programming.
- Proven ability to communicate complex statistical concepts to cross-functional teams.
- Experience contributing to regulatory submissions (e.g., BLA, NDA, MAA) is a plus.
- Strong analytical, organizational, and time-management skills to oversee multiple projects.