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Title:Principal Statistical Programmer
Salary:Open
Experience:8
Location:NJ - Jersey City

Description:
The Prinicpal Stat P/A will function in a project leader role by coordinating project(s) involving other members of Statistical Programming.

Responsibilities:
  • Function in a project leader role by coordinating project(s) involving other members of Statistical Programming.
  • Perform role of primary statistical programmer on all assigned studies, integrated summaries, and responses to requests from regulatory authorities.
  • Perform role of validation programmer on all assigned studies, assigned integrated summaries, and responses to requests from regulatory authorities.
  • Create data definition tables for all SDTM and derived data sets for all assigned studies and integrated summaries.
  • Create data mappings, SDTM and derived data sets, and data definition tables for all assigned partner studies.
  • Review statistical analysis plans for all assigned studies and integrated summaries and provides comments to study biostatistician.
  • Represent Statistical Programming on all assigned BPSS study teams.
  • Review annotated case report forms and provides comments to study database administrator.
  • Review edit check specifications and provide comments to study data manager.
  • Perform reviews of partner databases and data sets as part of due diligence efforts.
  • Provide technical expertise and consulting to Senior/Director of Statistical Programming.
  • Provide input to resource estimates to Statistical Programming and BPSS management.
  • Support direct supervisor and Senior/Director, Statistical Programming.
  • Provide leadership with respect to Statistical Programming, BPSS, and CDMA.
  • Maintains statistical programming binder for assigned studies, and integrated summaries.
  • Provide training, technical assistance, and mentoring to statistical programmers and senior statistical programmers.
  • Develops and provides feedback on standard operating procedures for all assigned Statistical Programming processes.
  • Represents Statistical Programming on all assigned groups and committees.

Requirements:
  • Masters Degree in Statistics, Biostatistics, Epidemiology, or Computer Science, or equivalent.
  • Eight (8) years experience performing statistical programming using SAS in a pharmaceutical setting, or equivalent.
  • Must have advanced knowledge of programming with SAS
  • Expert knowledge of clinical study process and experience with NDA submissions, including integrated summaries.
  • Strong oral and written communication skills.

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