Statistical Science Director - Early Oncology

AstraZeneca • Gaithersburg, MD

4d • $188,279 - $282,419 • Hybrid

About The Position

Are you ready to shape statistical strategy that advances transformative medicines for people living with cancer? Do you see yourself steering high-impact decisions from early discovery through regulatory approval and beyond, so patients benefit sooner? In this role you will be responsible in 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. You will provide 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. You will be holding CRO/Partners accountable for the high quality standards of their deliverables. You will represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organisations for specific projects/indications. You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration. You will mentor/coach and support the education and training of Statistics staff in the technical arena.

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.
• Provide 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.
• Represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organisations for specific projects/indications.
• Apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
• Mentor/coach and support the education and training of Statistics staff in the technical arena.

Benefits

• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health coverage
• Dental coverage
• Vision coverage
• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Director