Associate Director / Director Statistics

AstraZeneca • Gaithersburg, MD

67d • $177,877 - $266,816

About The Position

The Director, Statistics has sufficient experience in the pharmaceutical industry to independently lead a biometrics 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.

Requirements

• MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or relevant topic.
• 5+ years of experience for Associate Director level.
• 7+ years of experience for Director level.
• In-depth knowledge of technical/regulatory requirements with experience in pharm/healthcare.
• Up to date and implements novel statistical approaches.
• Experience with and broad awareness of regulatory interactions and/or submissions.
• Excellent communication skills and ability to build 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.

Responsibilities

• 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 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.

Benefits

• 401(k) plan
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees