Lead Biostatistician, Global Quality, Regulatory, Clinical Affairs

Cepheid

Bengaluru, India
On-site
Master's or phd in statistics
3 years industry experience
Advanced sas certification
Cepheid is seeking a Lead Biostatistician to support clinical trials and regulatory submissions in Bengaluru, India. The ideal candidate should possess advanced statistical qualifications and experience, with a focus on developing statistical analysis plans and programming in SAS. This role offers an opportunity to make a significant impact in the life sciences sector within a collaborative and innovative environment

Job Summary

  • The Lead Biostatistician will develop statistical analysis plans, oversee programming, and author final reports for FDA and regulatory submissions.
  • This role supports a culture of belonging within Cepheid, a Danaher operating company dedicated to innovating fast, accurate molecular diagnostic systems.
  • Candidates will administer statistical software licenses including SAS, JMP, and Minitab while providing independent programming support for R&D teams.

Matching Summary

Match Score: 85

Cepheid is seeking a Lead Biostatistician to support clinical trials and regulatory submissions in Bengaluru, India. The ideal candidate should possess advanced statistical qualifications and experience, with a focus on developing statistical analysis plans and programming in SAS. This role offers an opportunity to make a significant impact in the life sciences sector within a collaborative and innovative environment.

Skills & Requirements

Must-have

  • Master's or PhD in statistics
  • 3 years industry experience
  • Advanced SAS certification
  • Independent SAS macro development
  • DOE regression logistic regression multivariate analysis

Nice-to-have

  • R and Python programming proficiency
  • Mentoring junior biostatistics teammates
  • Experience with CE/IVD trials
  • Understanding of Danaher Business System

Key Requirements

  • Master's or PhD degree required
  • Minimum 3 years related industry experience
  • Basic and Advanced SAS certifications mandatory
  • Documented use in 3+ major submissions
  • Proficiency in DOE, ANOVA, and contingency tables

Work Rights

Not specified

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