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 (madeleine.wirz@swisselect.ch)*


* With reference to the General Data Protection Regulation we require your written consent in order to process and store your personal data.
Your consent applies to the application procedure with swisselect group.
Please note that you can revoke your consent at any time.

Zurück zur Übersicht