Job Title: Statistical Science Director
Introduction to role:
The Statistical Science Director has extensive experience working as a statistician in the pharmaceutical industry. This role involves leading the statistical strategy or technical activities related to design, delivery, and interpretation, high-level internal governance committees, and regulatory submissions of a project. The individual is recognized externally as a methodology expert and can lead, perform, and communicate results of complex analyses while guiding less experienced staff. This role requires excellent cross-functional collaboration.
Accountabilities:
The Statistical Science Director may lead a project and/or support statistical methodological advances. The accountabilities for supporting projects directly include:
- Lead the statistical design and strategy for product development plans, preclinical 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, interpretation, and submission.
- Quantify the benefit, risk, value, and uncertainty of the emerging product profile and 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 ESPC/LSPC.
- Mentor/coach and support the technical education and training of Statistics staff.
The accountabilities for supporting statistical methodological advances are (technical focus):
- In-depth knowledge of technical/regulatory requirements with experience in pharma/healthcare.
- Up-to-date implementation of novel statistical approaches.
- Experience with and broad awareness of regulatory interactions and/or submissions.
- Excellent communication skills/builds strong relationships.
- Nationally recognized externally. Invited to attend or speak at seminars and external meetings. Well-rounded statistician with publications on a range of topic areas. Publications resulting from external collaborations.
- Expert leadership role able to lead/direct work across a team.
Essential Skills/Experience:
Project:
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