Associate Director / Director Statistics

AstraZeneca • Gaithersburg, MD

7d

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. Statistics, Mathematics (containing a substantial statistical component), or relevant topic with 5+ yrs expeirence (Associate Director level)
• MSc/Phd. Statistics, Mathematics (containing a substantial statistical component), or relevant topic with 7+ yrs expeirence (Director level)

Responsibilities

• 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
• 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

• Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

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