The accountabilities for supporting projects directly include:
• To lead, manage and develop a group of statisticians
• Work according to agreed functional and regional SHE strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up and improvements
• 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 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