Lead Biostatistician, Global Quality, Regulatory, Clinical Affairs

Cepheid, a Danaher operating company

Bengaluru, India
On-site
Master's or phd in statistics
3 years 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 ideal candidate will have advanced degrees in statistics or related fields, along with substantial experience using statistical software. The position offers an opportunity to make a significant impact in the life sciences sector while fostering career growth

Job Summary

  • The Lead Biostatistician will support clinical trials by developing statistical analysis plans, overseeing statistical programming, and authoring final statistical analysis reports for regulatory submissions.
  • This role serves as the primary point of contact for FDA and other regulatory agency questions pertaining to study design and analysis within a culture that fosters career growth.
  • Candidates will administer statistical software licenses including SAS, JMP, and Minitab while providing statistical support to R&D teams and mentoring junior teammates.

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 ideal candidate will have advanced degrees in statistics or related fields, along with substantial experience using statistical software. The position offers an opportunity to make a significant impact in the life sciences sector while fostering career growth.

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

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