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Senior/Principal Biostatistician

  • Job type: Permanent
  • Location: San Francisco
  • Salary: $110000 - $150000 per annum, Benefits: benefits package + bonus
  • Job reference: MS413828
  • Sector: Biostatistics, EPM Scientific
  • Date posted: 13/04/2018
Senior/Principal Biostatistician
Salary: $110,000-$150,000
Location: San Francisco, CA

Do you want to join a cutting-edge pharmaceutical company as well as make a lasting impact on research and development? An innovative biotech company is currently expanding their Biostatistics group out of their San Francisco, CA site and is looking for a Senior/Principal Biostatistician. If you have experience with phase I-III  developing Statistical Analysis Plans/Study Designs, and FDA/ICH regulations, then this opportunity is for you!  

The Senior/Principal Biostatistician will be responsible for:
  • Responsible for writing statistical methodology section of the protocol, including sample size calculation.
  • Responsible for writing statistical analysis plans for individual studies and ISS/ISE.
  • Plan regulatory filings and ensure timely submissions.
  • Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports.
  • Contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes including IWRS/EDC, STDM, statistical programming for TLFs, and data reporting. 

The Senior/Principal Biostatistician should have:
  • Ph.D. in statistics/biostatistics with 2+ years of biopharmaceutical statistics experience or Ms with 5+ years of experience with drug development and submissions in the pharmaceutical industry
  • Knowledge of missing data handling, multiple comparisons, and simulation techniques.
  • Experience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions
  • Good working knowledge of ICH, FDA and GCP regulations and guidelines.
Company Benefits: 
Top-notch flexible benefit plans including 401k match/retirement fund and top-notch health insurance plans. This company is a strong believer in promoting work-life balance and offers generous PTO as well as Paternity/Maternity leave.