Statistical Science Director - Early Oncology

AstraZeneca • Gaithersburg, MD

1d • Hybrid

About The Position

This role offers the opportunity to shape statistical strategy for transformative medicines in oncology, steering high-impact decisions from early discovery through regulatory approval to benefit patients sooner. As a Statistical Science Director at AstraZeneca, you will lead statistical contributions to Development Plans, Regulatory Strategy, Health Technology Assessment, and Commercial Presentation for specific product teams. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for serious diseases. The company fosters an inclusive environment where employees are empowered to push scientific boundaries, challenge conventions, and drive change to meet global healthcare and sustainability challenges. AstraZeneca is committed to lifelong learning, growth, and development, valuing diversity as fundamental to innovation. The company aims to create an equitable environment where people belong, connecting different thinking to generate new opportunities and deliver life-changing medicines.

Requirements

• MSc or PhD degree in Statistics, Biostatistics, or related quantitative fields, or equivalent course work/ technical experience
• Understanding of regulations/developments in the area of Clinical Development and Biostatistics
• 5 years experience as a statistician with clinical trials, pharmaceutical development, regulated research, and/or related areas of statistical applications
• A collaborative mindset
• A general dedication to and ability to apply expertise to problem solving
• Experience with relevant statistical software
• Ability to apply statistical techniques in the analysis of data from clinical studies

Nice To Haves

• TA or disease area knowledge expertise
• Exposure to business development opportunities (e.g.in licencing)
• Project management skills
• Proficiency in programming SAS and/or R and Python

Responsibilities

• Leading the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team.
• Providing leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ standards and external regulations.
• Through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions.
• Quantifying the benefit, risk, value and uncertainty of the emerging product profile.
• Holding CRO/Partners accountable for the high quality standards of their deliverables.
• Representing AZ and Statistics to Health Authorities and Reimbursement/Payer Organisations for specific projects/indications.
• Applying expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
• Mentoring/coaching and supporting the education and training of Statistics staff in the technical arena.

Benefits

• eligibility for various incentives—an opportunity to receive short-term incentive bonuses
• equity-based awards for salaried roles
• commissions for sales roles
• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health coverage
• dental coverage
• vision coverage

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