Senior Statistical Programmer Job at cGxPServe, Worcester, MA

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  • cGxPServe
  • Worcester, MA

Job Description

Responsibilities:
  • Ensure departmental or functional training plans in place and appropriate.
  • Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget.
  • Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications.
  • Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications.
  • Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Maintain complete and auditable documentation of all programming activities.
  • Manage datasets and output across SAS programs, studies, and indications to ensure consistency.
  • Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests.
  • Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
  • Develop and/or maintain departmental procedures and standards
  • Review CRFs, edit check specifications, and table, figure, and listing mock-ups.
  • Manage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer's guide documents.
  • Assist in validation of SAS per 21 CFR Part 11.
  • Train and mentor new members and programmers; supervise contract programmers, as needed.

Requirements:

  • Bachelor's degree in Statistics, Mathematics, Computer Science or a related field required.
  • Minimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmer.
  • Prior experience overseeing statistical programming contractors required.
  • Compound oversight experience highly preferred.
  • Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferred.
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
  • eCTD NDA submission experience is a must.

Job Tags

Contract work, For contractors,

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