Vacancy expired!
Biometrics Team Leader/Senior Director - Global Medical Affairs/Payer Biometrics
Locations: Cambridge or Macclesfield (UK); Gaithersburg or Wilmington (Delaware) (US); Warsaw (PO) or Mississauga (CA) Competitive salary and benefits package on offerDo you have a passion for science, statistics and leadership? Are you up for the challenge to impact a company that follows the science and turns ideas into life changing medicines? If yes, we welcome you to join AstraZeneca!At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide, while applying leading edge approaches to science across many business areas. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to act, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.We are currently looking for a Biometrics Team Leader/Director to lead, manage and develop a group of statisticians who work within our Global Medical Affairs (GMA) and Payer Biometrics statistics group which sits within Oncology Biometrics.The Biometrics Team Leader/Director reports to the Head of GMA/Payer Biostatistics and is accountable for operational planning and delivery of services to the groups two key stakeholders, GMA and Oncology Market Access and Pricing (OMAP). For GMA, the group provides statistical support for interventional and Real World Evidence (RWE) studies, including developing design options and providing high quality decision support. For OMAP, the group provides statistical support for the Global Oncology Payer Function via the application of quantitative skills to support decision-making processes and value demonstration, including contributing to Health Technology Assessment (HTA) submissions.What you will do:The main duties and responsibilities of the role will include;- To lead, manage and develop a group of statisticians, ensuring the successful delivery of projects while simultaneously considering the development needs of statisticians.
- Efficiently utilize resource in the group and beyond to deliver key projects to time, quality and within resource constraints.
- Design and analysis of interventional and non-interventional studies (incl. sample size estimation and randomisation specification.)
- Developing statistical analysis plans for complex studies and/or project deliveries.
- Contributing to protocols, clinical study reports, regulatory documents and manuscripts.
- Providing support to the payer function for late stage oncology assets. Including post hoc analysis of clinical trial data to support development of cost effectiveness and budget impact models.
- Representing AstraZeneca to Health Authorities and Reimbursement & Payer Organizations for specific projects
- Analysis of published literature and RWE sources (e.g. network meta-analysis and synthetic control arms).
- Dependent on experience, mentoring of more junior staff and presenting at internal training seminars.
- MSc or Ph.D. Statistics, Biostatistics, or Mathematics (containing a substantial mathematical component).
- Experience in drug development, study design, and data analysis and interpretation.
- Experience of leading projects and people in a pharmaceutical or CRO environment.
- Publication experience and/or experience of presenting at external meetings (e.g. ISPOR, PSI)
- Programming expertise in R, WinBugs and/or SAS.
- Experience of reimbursement submissions in key markets (e.g. UK and Germany.).
- Regulatory submission experience in key markets (e.g. EU and USA.)
- Application of indirect comparison methodology (e.g. Bayesian/Frequentist NMA and MAIC/STC methodologies).
- Experience of performing adjustment for treatment switching/cross-over within clinical trials (e.g. RPSFT and IPCW methodology.).
- Analysis of health utility data including mapping and value set application.
- Application of causal inference models to clinical trial and RWE data.
- Experience of working with RWE datasets and registries (e.g. Flatiron.).
Vacancy expired!