Statistical Science Director - Early Oncology
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. When we put unexpected teams in the same room, we unleash bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.
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, dental, and vision coverage in accordance with the terms of the applicable plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
