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    Senior Statistical Programmer

    Navitas Life Sciences
    10+ years
    Not Disclosed
    Remote, USA
    10 July 26, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Senior Statistical Programmer Analyst I (SR SPA I)

    The Senior Statistical Programmer Analyst I (SR SPA I) operates independently to support clinical reporting, statistical programming, and verification activities for client regulatory submissions and publications.

    Key Responsibilities:

    • SAS Programming & Analysis:

      • Perform SAS programming to generate analysis datasets, statistical analysis, listings, figures, and tables.
      • Develop SAS application code independently.
      • Validate SAS programs and deliverables to ensure accuracy.
      • Conduct migrations and verifications.
      • Perform SDTM and ADaM mapping.
      • Produce SDTM and ADaM deliverables.

    • Output Generation:

      • Generate all necessary output for compiling statistical appendices for Clinical Trial Reports (CTR), Integrated Summary of Safety (ISS), and Integrated Summary of Efficacy (ISE).
      • Create data files and output for safety updates, publications, and meeting presentations.

    • Client and Team Interaction:

      • Interface with a cross-functional team, including both client and DataCeutics members.
      • Serve as an expert in specialized areas such as Project Management, Statistical Computing Environment (SCE), SDTM, ADaM, define.xml, SAS programming, deliverables process, tables, graphics, PK/PD, and registries.

    Desirable Skills and Experience:

    • Educational Background & Experience:

      • Strong foundation in statistics and statistical analysis.
      • Over 10 years of experience in the pharmaceutical or Clinical Research Organization (CRO) industry, focusing on clinical reporting and statistical programming.

    • Technical Competence:

      • Proficiency in SAS/Base, SAS/Macro, and SAS/STAT programming.
      • Working knowledge of CDISC standards, particularly SDTM and ADaM.
      • Expert-level knowledge in SAS-based statistical programming.
      • Experience with SAS programming on multiple platforms and operating systems, such as Windows and UNIX, is highly desirable.

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