Associate Director SAS Programmer

7/15/22

Waltham, MA

1762

Principal / Associate Director SAS Programmer

Our client is seeking a Senior/Principal SAS Programmer who will provide statistical and clinical programming support to the Clinical Development department and other functional areas upon request. The successful candidate will work independently and as part of a multifunctional team. Activities will include, but are not limited to review SAPs, CRFs, Edit Specifications, development/validation of SAS programs and macros in support of clinical study data output [tables/listings/figures (TLFs)], and ad-hoc statistical analyses.

Responsibilities:

  • Creates and validates TLFs and derived datasets using SAS for internal and regulatory deliverables including submission.
  • Performs ad-hoc programming requests as required to support the Clinical Development department.
  • Validate/Review CRO deliverables: SDTM, ADaM, and TFLs including the specifications.
  • Reviews and provides feedback on case report form designs, CRF annotations, DB structures, edit checks, and SAPs
  • Creates mapping specifications for derived datasets.
  • Provides direction/oversight of statistical programming work being conducted by CROs, and contractors.
  • Review/Validate define package to ensure its submission readiness.
  • Assist in the review, synthesis and interpretation of analysis results.
  • Streamline programming process by adopting internal and regulatory standard and macros.
  • Oncology experience is preferred.

Requirements:

  • Education: B.Sc. / M.Sc. in Statistics, Mathematics, Computer Science, Engineering or a related field. M.S. preferred.
  • At least 6 plus years of experience with SAS in pharmaceutical, biotechnology industry or CRO is required.
  • Previous experience in converting and/or creating datasets in CDISC (Clinical Data Interchange Standards Consortium) format is required.
  • Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro language
  • Good knowledge of clinical trial design concepts.
  • Excellent communication and interpersonal skills.
  • Leadership in both macro development and process streamlining.
  • Submission experience including m5 package preparation.
  • Knowledge of relevant regulatory guidelines and standards (e.g., FDA, ICH and EMA).
  • Solid interpersonal and teamwork skills.

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