Senior Project Biostatistics Lead (associate Director) - Vaccines

Sanofi

Waltham, MA, United States
$148,500.00 - $247,500.00 py
On-site
Clinical development plan
Statistical analysis plan
Regulatory authorities acceptance
Sanofi is seeking a Senior Project Biostatistics Lead (Associate Director) for its vaccines division in Waltham, MA. This role involves leading statistical aspects of clinical development and post-marketing studies, requiring a strong background in biostatistics and project management

Job Summary

  • Lead Biostatistician for medium complexity vaccine project accountable for all statistical aspects of clinical development/medical affairs plans, studies and submissions activities.
  • Develop end-to-end clinical development plans, propose alternative trial designs, and represent statistics in cross-functional working groups.
  • Accountable for the statistical aspects of submission for marketing authorization, ensuring quality data analyses and CDISC package compliance.

Matching Summary

Match Score: 85

Sanofi is seeking a Senior Project Biostatistics Lead (Associate Director) for its vaccines division in Waltham, MA. This role involves leading statistical aspects of clinical development and post-marketing studies, requiring a strong background in biostatistics and project management.

Salary

$148,500.00 - $247,500.00

Skills & Requirements

Must-have

  • clinical development plan
  • statistical analysis plan
  • regulatory authorities acceptance
  • clinical trial execution
  • submission for marketing authorization
  • CDISC packages compliance
  • SAS, R, Office computer skills

Nice-to-have

  • innovative approaches
  • scientific interpretation of results
  • cross-company activities
  • cross-cultural communication

Key Requirements

  • Ph.D. in Biostatistics, Mathematics or related discipline with minimum 6 years biostatistics experience in pharmaceutical industry OR MS in Biostatistics, Mathematics or related discipline with minimum 8 years biostatistics experience in pharmaceutical industry
  • Proven experience in clinical development or post-marketing activities
  • Strong project management & interpersonal skills
  • Broad knowledge of advanced statistical concepts
  • Effective English oral and written communication skills

Work Rights

Not specified

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