Senior Statistical Programmer


Penfield Search Partners

Contact: Linda Aronova –

Job Description: The Senior Statistical Programmer will be a primary resource for the development and validation of programs which create datasets and CDISC standards, as well as Tables, Listings, and Figures (“TLFs”) for analysis purpose.  He/she will develop specifications to ensure that statistical programming elements are in line with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. He/she will support the Programming Lead and may represent Statistical Programming in meetings with internal and external clients and cross-functional project teams.  The Senior Statistical Programmer will act as a mentor to Statistical Programmers and Associate Statistical Programmers. He/she must demonstrate, at a minimum, a strong ability to comprehensively integrate statistical concepts with SAS Programming in a most efficient and effective manner.

Principal Responsibilities

  • Support development of technical programming specifications for SDTM,ADS or ADaM standards.
  • Independently develop and/or validate programs that generate SDTM and analysis datasets or ADaM specifications.
  • Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP.
  • Independently develop and validate programs that generate tables, listings, figures/graphs using company specifications.
  • Manage external vendors and contract programmers.
  • Provide project progress updates of programming activities.
  • Review, maintain, and approve protocol specific documents as necessary.
  • Provide guidance and mentoring to peer, junior-level Programmers and contract staff.
  • Support project leadership ensuring that department standards are implemented in all studies.
  • Contribute ideas and thoughts towards the optimization of standard operating procedures.
  • Lead team meetings when appropriate.
  • Any other activities as required.


  • BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
  • Minimum of 4 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
  • Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
  • Independently and collaboratively resolve problems
  • Clearly communicate processes and standards with management and team members
  • High competence in using SAS/Base, SAS/Macro, SAS/STAT.
  • Knowledge of SAS/Graph, and SAS/SQL

Knowledge and implementation of:

  • SDTM and ADaM principals
  • Relational Databases.
  • Good Clinical Practice principals.
  • Good Programming Practice principals.
  • 21CFR Part 11 Standards principals.
  • Integrated Summary Safety/Efficacy Analyses.
  • Safety data and Coding Dictionaries (MedDRA and WHODD).
  • ICH eCTD format.


Tagged as: Senior Statistical Programmer