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Principal - Manager Statistical Programming

  • Job type: Permanent
  • Location: San Francisco
  • Salary: $110000 - $140000 per annum, Benefits: complete benefits package
  • Job reference: MASL02052018326
  • Sector: Biostatistics, EPM Scientific
  • Date posted: 05/02/2018
Exciting Career Growth Opportunity with growing Pharmaceutical company:
  • Principal to Manager Level Statistical Programmer
  • Palo Alto, CA
  • $110,000-140,000 + Complete benefits package

My client is Seeking a Principal to Manager level statistical programmer who has at least 7 years of experience working within Statistical Programming, has experience with analysis of complex data collected from stage I-IV clinical trials, and has a solid understanding of SAS. They will serve as a manager to a team of 10-15 highly technical statistical programmers supporting clinical trials.

 

This role will be responsible for:
  • Provide guidance as well as support to clinical trial statistical programming teams,
  • Responsible for reviewing and approving CDISC compliant datasets as well as providing electronic documents necessary for correspondence with regulatory agencies.
  • Responsible for writing, testing, and validation of SAS programs to be used for analysis from clinical trial datasets, (i.e, Tables, Listing and Graphs) needed for reports submitted to regulatory agencies
  • Report to Senior Manager of Stat programming and work with project teams to put in place strategies and timelines for project plans
  • Represent the programming function at meetings with cross functional departments
  • Must revise drafts of multimedia such as clinical reports, journal publications, power-point presentations, and additional documents to ensure accurate representation of data.
  • Clear Understanding of pharmaceutical clinical development (i.e. understanding safety deliverables, efficacy analysis) and ability to provide programming support needs for BLA and other regulatory submissions
  • Ability to create and adhere to company SOP’s related to clinical programming
  • Responsible for oversight of external vendors and contract programmers
 

A successful candidate will have:
  • A minimum of 7 years of experience in Statistical Programming
  • Experience within in the Life Sciences of Pharma Industry
  • Previous experience as a lead Statistical Programmer for NDA’s/BLA’s
  • Excellent communication skills
  • Masters Degree highly recommended
  • Experience as a lead programmer for NDAs/BLAs
  • Proficient in SAS programming, knowledge of an additional language is encouraged
  • Understanding of CDISC standards, including SDTM and ADaM models
 

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