Biotech/Pharmaceutical

Lead Biostatistical Programmer I, II or III

Permanent

Penfield Search Partners

Contact: Linda Aronova – 646.882.9021 – laronova@penfieldsearch.com

Job Summary: The Lead Biostatistical Programmer I, II or III is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials, and leading project teams.

Essential Functions/Key responsibilities: Function as a Lead programmer for a compound or a group of studies performing the following functions:

  • Maintain the overall timeline for his/her studies.
  • Maintain the programming standards for his/her studies.
  • Review standard macros used.
  • Review standard datasets used.
  • Discuss need for programming resources for their group of studies.
  • Mentor/Train junior programmers on company systems and standards as they work on studies within their area.
  • Assist junior programmers in new study set-up to help identify similar studies.
  • Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored.
  • Check that the validation summary reports are clean of errors and warnings and show proper documentation of SAS programs.
  • Review individual study CDISC validation output.
  • Act as a Programming lead for a submission project under supervision of Programming management.
  • Other responsibilities, as required.

Qualifications: Minimal acceptable level of education, work experience, and competency:

  • Bachelors degree in Statistics, Mathematics, Computer Science or health related field. Masters is preferred.
  • Minimum 5 years of programming experience using SAS Base/Stat/Macro/GRAPH in the biopharmaceutical and/or CRO industries.
  • Data Management experience and knowledge of CDISC standard are highly desirable.
  • Good SAS programming skills and attention to detail are essential.
  • Demonstrate knowledge of regulatory biostatistics, SOPs, and guidelines.
  • Highly motivated and able to work well independently.
  • Strong organizational, time management, communication and project coordination and leadership skills.
  • Must be able to work well under timeline pressure.
  • Must be able to work on multiple tasks while coordinating others at the same time.

Tagged as: Lead Biostatistical Programmer I, II or III