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Clinical Trial Statistical Programmer

Employer
Principia Biopharma
Location
South San Francisco, California, United States
Start date
Sep 8, 2019

View more

Discipline
Clinical, Clinical Trials, Information Technology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
Responsibilities:

This position will report to Director Biostatistics and the Clinical Trial Statistical Programmer will have primary responsibility for overseeing data quality and data reviews. He/she will be responsible for developing automated analyses and visualizations in R and Tableau to facilitate the evaluation of data quality and review at the individual clinical study level as well as accumulating data across multiple clinical studies.

Specifically:
  • Ensure data integrity through oversight of routine data reviews, query and resolution.
  • Lead cross-disciplinary data review meetings with all stakeholders, including clinical, statistical and operational subject matter experts.
  • Establish consistency in review of data quality and review across programs

Qualifications:
  • Bachelor's Degree, Master's Degree or higher in statistics, biostatistics, data science or computer science
  • Experience with programming customer friendly patient profiles in Tableau or other program
  • R or Python programming skills, preferably including ggplot, tidyverse and R Markdown
  • Ability to clearly communicate complex issues, observations and resolutions to management
  • Understanding of statistical concepts related to the design and conduct of clinical trials
  • Broad experience in data collection, monitoring, cleaning and analysis throughout clinical development (Phase 1-4) preferred
  • Prior employment at a pharmaceutical or biotech company or CRO preferred

Skills/Competencies
  • Understanding of statistical concepts related to the design and conduct of clinical trials
  • Broad experience in data collection, monitoring, cleaning and analysis throughout clinical development (Phase 1-4) preferred
  • Previous employment at a pharmaceutical or biotech company or CRO preferred
  • Experience explaining results of analyses to non-technical audiences.
  • Working knowledge of MS Office suite. Able to generate business correspondence, create forms and generate reports as required
  • Have excellent time management skills and are action-oriented, goal-oriented and innovative.
  • Experience leading data review discussions and meetings preferred

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