Senior Statistical Scientist

 
Published
WorkplaceBasel, North West Switzerland, Switzerland
Category
Position

Description

Senior Statistical Scientist

Switzerland, Basel-City, Basel

The Statistical Scientist partners with colleagues in Clinical Science, Safety Science, Regulatory, Research, and Manufacturing on clinical development projects, research applications, development science applications, and/or product manufacturing applications. This typically includes partnering with Senior Statistical Scientists in the creation of strategies to address drug development needs and designing experiments, and evaluating and preparing study results for Health Authorities and the medical/research community. 

Accountabilities

Clinical Development

  • A member of cross-functional Study Management Teams.
  • Study Planning: in collaboration with Senior Statistical Scientists, reviews study protocols, authors statistical sections of protocols.
  • In collaboration with Senior Statistical Scientists, develops independent data monitoring and endpoint committee charters.
  • Develops the statistical and data analysis plans, and prepares the study randomization.
  • Study Conduct: reviews case report forms to ensure protocol objectives are met and project standards are maintained; develops statistical programs as necessary to perform analyses, review analyses produced by statistical programming, ensuring the accuracy & validity of results.
  • Analysis & Reporting: author the clinical study report, and in collaboration with Senior Statistical Scientists and cross-functional team members, provides input into global health authority documents and regulatory response for health authority submissions.
  • Contributes to study publications and presentations, and provides analytical support for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.

Nonclinical Statistics

  • Study Planning: in collaboration with senior staff, provides experimental design and analysis strategies to nonclinical projects in Research, Preclinical Development Science, Bioprocess Development and Manufacturing.
  • Analysis and Reporting: With assistance from senior staff, performs statistical analyses for nonclinical studies, provides input to IND and BLA submissions and to regulatory response to global health authority investigations related to marketed products, and contributes to publications and presentations.
  • Statistical Consulting: With assistance from senior staff, provides statistical advice to nonclinical investigators and contributes to the development of statistics courses.

Qualifications & Competencies

  • MSc or PhD in Statistics, Biostatistics, Mathematics or similar areas of academic discipline.
  • Good knowledge of English in a business environment.
  • Experience in using statistical software.
  • Good knowledge of theoretical and applied statistics.
  • Developing knowledge and experience applying statistical methods to drug development.
  • Developing understanding of regulatory guidelines in a pharmaceutical research setting.
  • Good Communication and Collaboration Skills
  • Evident Project management skills

Roche is an equal opportunity employer.

Research & Development, Research & Development > Biometrics

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In your application, please refer to myScience.ch and reference JobID 47996.


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