Statistical Science Director, Boston MA
AstraZenecaAbout the role
Statistical Science Director
Location: Boston, MA
The Statistical Science Director has sufficient experience working as a statistician in the pharmaceutical industry to be accountable and independently lead the statistical strategy or technical activities related to design, delivery and interpretation, high level internal governance committees and/or regulatory submissions of a project. This individual is able to lead, perform and communicate results of more technical analyses, and able to guide less experienced staff. Competent individual contributor with excellent cross-functional collaboration.
Typical Accountabilities:
The Statistical Science Director will typically lead a project. The accountabilities for supporting projects directly include:
• Lead the statistical design and strategy to product development plans, clinical studies, regulatory strategy, health technology assessment and/or commercial activities as appropriate for the stage of the product
• Lead the statistical content and ensure quality for study designs, documents, delivery and interpretation and submission
• Quantify the benefit, risk, value and uncertainty of the emerging product profile and can communicate these effectively within the team
• Provide global leadership to others and direct project work delivered by internal and external staff
• Partner with CROs to ensure delivery to quality and time
• Represent AZ externally which may include health authorities, advisory boards, conferences, workshops and/or payer interactions
• Maintain knowledge of statistical methodology in relevant areas and promote, investigate and implement novel statistical approaches
• Represent statistical strategy and decision making at internal decision-making governance including review boards, therapy area leadership teams and internal governance committees
• Mentor/coach and support the technical education and training of Statistics staff
Education, Qualifications, Skills and Experience:
Essential:
• MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognised equivalent to stats MSc
7+ yrs of experience of pharmaceutical development, data analysis and interpretation and experience of program design.
• Track record of background in leading independently
Experience with and broad awareness of regulatory interactions and/or submissions
• Exemplary technical skills
Excellent communication skills/ builds strong relationships
Desirable:
• TA or disease area knowledge expertise
• Exposure to business development opportunities (e.g.in licencing)
• Project management skills
• Proficiency in
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