Director, Biostatistics

This is what you will do

The Director, Biostatistics has sufficient experience in the pharmaceutical industry to independently lead a biostatistics team to deliver project and / or technical level activities related to design, delivery and interpretation, high level internal governance committees and / or regulatory submissions. This individual is able to lead, perform and communicate results of more technical analyses, and able to guide and lead less experienced staff. Competent individual contributor with excellent cross‑functional collaboration.

Responsibilities

• Lead, manage, and develop a group of statisticians.
• Lead the statistical design and strategy to 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 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 Alexion 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 biostatistics staff.
• Work according to agreed functional and regional Safety, Health and Environment (SHE) strategy by ensuring proper management of SHE risks, incidents, reporting, follow‑up and improvements.

Qualifications

The duties of this role are generally conducted in an office environment. As is typical of an office‑based role, employees must be able, with or without an accommodation to : use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non‑linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Preferred Qualifications

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