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Sr. Statistical Programmer (Science & Biotech)
San Diego, CA 22434
Recruited by: Melissa Grover | Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: SimulStat Inc.
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Feb 08, 2019
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Job Description

Senior Statistical Programmer Job Description

This essential team member will be responsible for supporting the SAS statistical programming efforts for clinical and non-clinical projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of programming standards and procedures.

SCOPE AND RESPONSIBILITIES:

Ability to write SDTM and ADaM specs
Serve as the primary project team representative, delegating work as appropriate
Generate SDTM domains, ADaM datasets, and Define.xml files with proficiency in creating specification files for these domains
Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data.
Review output across programs to ensure consistency
Review, maintain, and approve study documents per standard procedures
Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
Program, test, and document global utility programs and tools in accordance with standards and validation procedures
Provide technical oversight and leadership in the areas of analysis and reporting
Participate in the development and/or maintenance of departmental procedures and standards
Train and mentor new programmers
DESIRED SKILLS & EXPERIENCE

BS degree in Statistics, Mathematics, or Computer Science or in a related field
Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer programming CDISC data structures
Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
Excellent communication and interpersonal skills to effectively work in a team environment