Senior Principal Biostatistician – 6764 URA

 

Our client is headquartered in Switzerland – a Innovation-hub of Europe – is a high-potential  biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options is looking a Senior Principal Biostatistician  for a initial 2 year contract based in Basel.

 

Main Responsibilities:

 

  • Provide strategic and scientific leadership and statistical solutions with a high degree of autonomy.
  • Provide statistical input to regulatory submissions, responses to authorities, and briefing documents.
  • Serve as statistical lead and strategic partner for one or more therapeutic areas, ensuring statistical integrity and consistency across studies.
  • Provide statistical leadership and input to the development of protocols, SAPs, and CSRs.
  • Lead the design, analysis, and interpretation of clinical trials along with mentorning statisticians
  • Own the quality and timeliness of statistical and programming deliverables.
  • Ensure compliance with regulatory standards.
  • Stay current on evolving regulatory guidance and methodological advances.
  • Collaborate closely with clinical science, data management, medical writing, programming and regulatory teams to drive quantitative decision making in drug development.
  • Influence decisions at program level.
  • Defend statistical positions in internal and external meetings, including regulatory interactions.

 Qualifications and Experience:

 

  • Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
  • Bachelors, Masters degree of Phd in mathematics, statistics, data science, or related quantitative discipline.
  • Atleast 10 years of extensive knowledge and expertise gained as a statistician or data scientist within the pharmaceutical industry
  • 3 years of experience in a leadership or supervisory role
  • Lead or key contributor to major regulatory submissions and successful interactions with FDA, EMA, or other health authorities
  • Knowledge of international clinical research regulations and requirements, pharmaceutical industry and of the scientific, clinical, and regulatory components in the drug development process
  • Proficiency in R
  • Strong interpersonal skills and the ability to develop good working relationships with internal colleagues and external collaborators
  • Ability to independently deal with complex and difficult situations, work under pressure, and prioritize tasks
  • Active participation in industry working groups, standards bodies, or peer-reviewed publications/presentations
  • Excellent communication and organizational skills
Apply for job