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    Senior Statistical Programmer

    Cytel
    6+ years
    Not Disclosed
    Remote, USA
    10 Aug. 6, 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

    Senior Statistical Programmer

    Join Cytel’s Collaborative Biometrics Team

    At Cytel, we drive healthcare forward with our innovative applications of statistical science and adaptive clinical trial design. As a global leader in biostatistics and operations research, we are dedicated to enhancing drug development success rates for the benefit of human welfare. We are experiencing significant global growth and are seeking Senior Statistical Programmers to join our FSP division. This role, which can be performed fully remotely, involves leveraging your expertise in CDISC standards (SDTM & ADaM) and advanced SAS programming to support or lead Phase I-IV clinical trials across various therapeutic areas.

    Our Values:

    • We apply scientific rigor to unlock the full potential of data.
    • We nurture intellectual curiosity and tackle new challenges with enthusiasm.
    • We embrace collaboration and diverse perspectives to foster innovation.
    • We seek intelligent solutions using cutting-edge technology.

    How You Will Contribute:

    • Perform data manipulation, analysis, and reporting for clinical trial data, including safety and efficacy, using SAS programming.
    • Generate and validate analysis datasets, tables, listings, and figures (TLFs).
    • Conduct production, QC, and validation programming, and create complex ad-hoc reports.
    • Apply strong expertise in Safety and Efficacy analysis.
    • Communicate with internal teams and clients regarding project specifications, status, and issues.
    • Lead assigned clinical studies under the guidance of principal programmers.
    • Demonstrate flexibility and adaptability to meet deadlines and changing priorities.
    • Create and review specifications for derived/analysis datasets and Non-CDISC transformation datasets.
    • Generate and validate submission documents and eCRTs.
    • Read and write specifications related to protocol and SAP, demonstrating a solid understanding of endpoints and data collection.
    • Advanced knowledge in SAS, including macro writing, and proficiency in R programming is a plus.

    What You Offer:

    • Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, or related field.
    • At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry (6 years with a Master’s degree or above).
    • Strong familiarity with the drug development lifecycle and clinical trial data analysis and reporting.
    • Experience with ICH E3 (Structure and Content of CSR) and E9 (Statistical Principles).
    • Advanced skills in SAS language, procedures, and options, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH.
    • Extensive experience with CDISC standards (SDTM and ADaM) and complex TLFs.
    • Strong QC/validation skills and good ad-hoc reporting capabilities.
    • Experience in pooling/ISS/SE studies and cross-over studies is a plus.
    • Submissions experience utilizing define.xml, annotated CRFs, data reviewer’s guides, and other submission documents.
    • Excellent analytical and troubleshooting skills.
    • Flexibility to adapt to and use client-specific macro codes.
    • R programming knowledge for data manipulation and graphing is an asset.
    • Ability to deliver high-quality outputs and meet challenging timelines.
    • Effective in a globally dispersed team environment with cross-cultural partners.
    • Applied experience in therapeutic areas such as oncology, rare diseases, gastroenterology, respiratory, immunology, hepatitis, or vaccines is a plus.
    • Experience in medical affairs is also a plus.

    Join us at Cytel and contribute to the advancement of clinical development through innovative statistical programming and a collaborative team environment.

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