We have an exciting opportunity for an RWE Statistician / Project Statistician in the Basel Area.
This is a 12 months’ contract (likely to be prolonged beyond a year)
RWE Statistician / Project Statistician
THE PRIMARY FOCUS of the RWE Statistician / Project Statistician is
- To conduct descriptive and comparative research of patient-level data from registries (e.g. Post-authorization safety studies / epidemiology and non-interventional)
- To support HA submission related deliverables (e.g. Submission Plan, Briefing Books, SAP) based on the registries
RESPONSIBILITIES AND TASKS
- Contribute to the statistical design of patient-level data registries
- Lead the development of the SAP(s) for interim and final reports
- Contribute to the exploratory analysis and communicate results through internal/external presentations and publications.
- Oversee and manage the statistical CROs and external partners (deliverables and relationship)
- Interact constructively with regulatory authorities on statistical issues
- Act as a Project Statistician
- Ensure statistical and scientific robustness of the study design and statistical analyses
- Present statistical aspects of study design, analyses and results in internal and external meetings
- Supervise and mentor a team of statisticians
- Safeguard adequate resource planning and adherence to timelines
REQUIRED QUALIFICATIONS AND EXPERIENCE
- MSc or PhD in Statistics, Epidemiology, Health Economics or related field with strong methodological and statistical background
- Demonstrated experience in clinical development or Epidemiology (pharmaceutical companies, biotech’s or CROs): At least 8 years of experience.
- At least 4 years in the role of a Senior Statistician
- At least 2 years in the role of a Project or Principal Statistician
- Experience with filing and submissions (NDA)
- Good working knowledge of SAS, CDISC, ADaM
- Talent to mentor junior statisticians and statistical programmers
- Will and skill to manage outsourcing activities
- Ability to work efficiently in a matrix-managed environment
- Business Proficiency in English
Are you interested in this challenging opportunity?
Then we look forward to your application via our online-portal or directly to Madeleine Wirz (email@example.com)*
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