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
Requirements
Associate Director level: MSc/Phd. Statistics, Mathematics (containing a substantial statistical component), or relevant topic with 5+ yrs experience
Director level: MSc/Phd. Statistics, Mathematics (containing a substantial statistical component), or relevant topic with 7+ yrs experience
In depth knowledge of technical/regulatory requirements with experience in pharm/healthcare
Up to date and implements novel stats approaches
Experience with and broad awareness of regulatory interactions and/or submissions
Excellent communication skills/ builds strong relationships
Nationally recognised 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
Benefits
Short-term incentive bonus opportunity
Eligibility to participate in equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
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