Senior Statistician - Early Oncology
Location(s) – Cambridge (UK), Permanent
Salary - Competitive salary and company benefits apply
Would you like to be a part of a Biostatisticial group who has direct strategic impact on drug development, playing a key role in getting medicines to patients?
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue premier medicines in new ways, combining our people’s extraordinary skills with those of people from all over the globe
As a Senior Statistician, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.
Focus & Challenge of Position
- Provide statistical leadership in support of the Global Product Statistician (GPS), be a newly appointed GPS, or lead strategic capability or business area improvements with minimal supervision
- Serve as primary author for statistical sections of protocol concept sheets (PCS), protocols, clinical development plans (CDP), and integrated product development plans (iPDP)
- Perform statistical analyses and create statistical text for clinical publications and other communications
- Provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work, holding partners/providers accountable for the quality of their deliverables
- Define and lead analysis of relevant internal and external information to inform design decisions
- Provide statistical support and leadership to clinical trial teams (CTT), clinical sub-teams (CST) and product development teams (PDT) on the development of Target Product Profile and Target Product Claims (TPP/TPC), Benefit, Risk, Value and Uncertainty (BRV(U)), clinical development plans (CDP), and regulatory strategy
- Lead development of components of regulatory submissions (eg, briefing documents, response to FDA requests, BLA/NDA, and sBLA/sNDA) and may represent AZ Statistics to Health Authorities (eg, Pre-IND and End of Phase II meetings)
- May provide highly experienced expert statistical leadership to the development of the capability area and to PDTs, promoting good statistical practice
- To represent the company’s position in their contacts with external experts
- May also participate in providing statistical support/strategy for post-marketing/Medical Scientific Affairs activities
- Requires juggling multiple projects with varying priorities. Requires ability to recognize issues that may critically affect statistical analyses and to relay that information to appropriate level of management
- Minimal supervision, appropriately and pro-actively consulting with key stakeholders (eg, GPS) and line management where needed to ensure a successful outcome to agreed time, cost and quality
Knowledge, Skills & Experience Required
- MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
- In depth knowledge of the technical and regulatory requirements related to the role
- Expert leadership capabilities to be able to lead and direct project work
- Extensive experience of Development, programme design and data analysis and interpretation
- Experience of major regulatory interactions and/or submissions
- Excellent communication skills and ability to build strong relationships
- Excellent collaboration skills required – the energy to work across global & functional boundaries, both internally and externally
- Ability to apply statistical expertise to complex problems, problem solving and quality focus
Next Steps -- Apply today
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.