Statistical Programmer/Senior Statistical Programmer

Location
South San Francisco, CA, United States
Posted
Oct 01, 2020
Ref
151632267
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Statistical Programmer/Senior Statistical Programmer

Position Overview:
The Statistical Programmer/Sr Statistical Programmer will be responsible for assigned statistical programming activities for one or multiple projects for clinical development. This individual will support the statistical programming lead and review CRO statistical programming deliverables. This position will report to the Director, Statistical Programming.

Duties and Responsibilities:
  • Review SDTM specifications and perform dataset acceptance test
  • Create and QC analysis dataset specifications and datasets for clinical trials
  • Implement statistical analysis plan, generate and QC TFLs within timelines
  • Generate and QC TFLs for publication, decision making and data review
  • Create and maintain documentation for programming activities
  • Review CRO statistical programming deliverables and perform acceptance check and validation
  • Assist in the creation and maintenance of broad use SAS macros
  • Review related clinical study documents and provide statistical programming feedback
  • Work collaboratively with internal cross-functional study teams
  • Provide statistical programming support and analyses beyond as needed by the biostatisticians

Qualifications:
  • Bachelor's degree or advanced degree in statistics, computer science or other relevant scientific field.
  • Minimum of 4 years of experience in statistical programming and analysis of clinical trial data in pharmaceutical/biotech industry
  • Experience of NDA/BLA submission preferred
  • Experience of CRO oversight preferred


Skills/Competencies:
  • Demonstrated proficiency in SAS programming for data analysis in clinical trials
  • Knowledge of programing practices and concepts, and relevant regulatory guidelines
  • Knowledge of CDISC standards and Pinnacle 21 validator
  • Ability to apply programming knowledge and skills to problem solving for team
  • Ability to clearly communicate complex issues and articulate technical ideas to non-technical audiences
  • Ability to manage concurrent projects in a fast-paced environment
  • R programming skills, including R Markdown and R Shiny preferred

Principia Biopharma is an equal opportunity employer.