Lead Biostatistician, Global Quality, Regulatory, Clinical Affairs

Cepheid, a Danaher operating company

Bengaluru, India
On-site
Master's or phd in statistics
3 years related industry experience
Advanced sas programming proficiency
Cepheid, a Danaher operating company, is seeking a Lead Biostatistician in Bengaluru, India, to support clinical trials and regulatory submissions through statistical analysis and programming. The role requires advanced statistical expertise, programming skills, and a commitment to life sciences innovation within a collaborative and growth-oriented culture

Job Summary

  • The Lead Biostatistician will support clinical trials by developing statistical analysis plans, overseeing programming, and authoring final reports for regulatory submissions.
  • This role serves as the primary point of contact for FDA and other regulatory agencies regarding study design and analysis questions.
  • Candidates will have the opportunity to mentor junior team members and administer statistical software licenses including SAS, JMP, and Minitab.

Matching Summary

Match Score: 85

Cepheid, a Danaher operating company, is seeking a Lead Biostatistician in Bengaluru, India, to support clinical trials and regulatory submissions through statistical analysis and programming. The role requires advanced statistical expertise, programming skills, and a commitment to life sciences innovation within a collaborative and growth-oriented culture.

Skills & Requirements

Must-have

  • Master's or PhD in statistics
  • 3 years related industry experience
  • Advanced SAS programming proficiency
  • Statistical analysis plan development
  • DOE regression and multivariate analysis

Nice-to-have

  • R and Python programming experience
  • Mentoring junior biostatistics teammates
  • Experience with CE/IVD trials
  • SAS certified advanced programmer status

Key Requirements

  • Master's or PhD degree required
  • Minimum 3 years industry experience
  • Documented use in 3 major submissions
  • Basic and Advanced SAS certifications
  • Independent macro development capability

Work Rights

Not specified

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