Statistician Leader

1 week ago

Bengaluru, Karnataka, India beBeeBiostatistician Full time ₹ 19,99,815 - ₹ 25,39,840
Senior Biostatistician Role

We are seeking an experienced Senior Biostatistician to join our cross-functional development teams.

The successful candidate will contribute to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.

  • Develop expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate.
  • Contribute to the preparation of the development strategy that will allow for effective and safe utilization of the product.
  • Drive the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use.
  • Translate scientific questions into statistical terms and statistical concepts into layman terms.
  • Challenge collaborator assumptions and positions based on facts and provide insights and perspective based on available information.
  • Ensure that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis.
  • Communicate effectively with clinical and regulatory partners and external opinion leaders.
Requirements

To be successful in this role, you will need:

  • 7+ years of experience in biostatistics or a related field.
  • Master's degree in Statistics or equivalent.
  • Ph.D. in Statistics or equivalent & ≥ 4 years of industry-related experience.
  • Ability to work successfully within a global cross-functional team leading to successful regulatory filings and approvals.
  • Excellent verbal and written communication skills.
  • Ability to be flexible and adapt quickly to the changing needs of the organization.
  • Ability to organize multiple work assignments and establish priorities.
Preferred Qualifications

Prior experience in the following areas would be beneficial:

  • Extensive knowledge of statistical/clinical trials methodology as it relates to clinical development.
  • Demonstrated data analysis planning, execution, and delivery experience in multiple clinical development settings.
  • Past submission and regulatory interaction experience.

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