Principal, Statistical Programmer

Clinical Development South San Francisco, California


Description

  • Lead on clinical studies and manage/provide training to lower level personnel when needed.
  • Contribute and implement to statistical analysis plans; provide additional expertise in the analysis of clinical trial when it relates to protocol development, case report form design and data collection. 
  • Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
  • Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP)
  • Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer’s Guide for Electronic Submission.
  • Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
  • Help identify issues and initiates resolution of the problems.
  • Act as a liaison between statistical programming, subcommittees and project teams as needed.   
  • May serve as external spokesperson for the organization.
  • Create/acquire tools to improve programming efficiency or quality.
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

Qualifications:

  • Ability to use professional concepts to achieve objectives in innovative and efficient ways.
  • FDA submission experience is a must.
  • Experienced in managing programming staff.
  • Solid knowledge of CDISC standard (SDTM & ADaM).

Experience:

  • Minimum 10 years Pharmaceutical/Biotech programming experience with two years of people management experience.
  • NDA submission experience is a plus.
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.

Education Requirements (degree, certifications, etc.): Include must have and preferred

  • BS/MS in Statistics, Math or Scientific Discipline.