Senior SAS Programmer - Cambridge, United States - IntePros

    IntePros
    IntePros Cambridge, United States

    3 weeks ago

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    Description

    RESPONSIBILITIES:

    • Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.
    • Offer technical support and expert advice to internal and external sponsors.
    • Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.
    • Implement programming and project standards in accordance with the Statistical Analysis Plan.
    • Act as a liaison between clinical management, subcommittees, and project teams.
    • Use efficient programming techniques to produce and quality-check derived datasets, tables, figures, and data listings.
    • Convert program specifications into SAS code for datasets and outputs.
    • Lead overall project delivery, including clinical trial reports and regulatory submission deliverables.
    • Create statistical analysis outputs for final reports, abstracts, posters, manuscripts, and other clinical publications.
    • Assist in establishing standardized programming procedures and work instructions.
    • Develop, evaluate, and validate standardized macros and utility programs.
    • Assist in developing client proposal documents.
    • Provide leadership, project management, and resource management for programming tasks supporting clinical trial activities.
    • Provide input into statistical programming timelines and negotiate timelines.
    • Mentor statistical programmers and provide input into documents produced by other functions.
    • Keep updated on statistical programming techniques and technical advancements.
    • Interact with regulatory agencies regarding electronic submission specifications.
    • Monitor project resourcing, budgets, and scope changes.
    • Ensure the quality, traceability, and timeliness of programming deliverables.
    • Participate in process/quality improvement initiatives.
    • Provide consultancy to internal and external sponsors on statistical programming tasks.
    • Ensure compliance with relevant regulatory requirements.

    EDUCATION:

    • Bachelors degree in Computer Science, Mathematics, Statistics, Life Sciences, or related field.

    EXPERIENCE:

    • Minimum of 6 years of experience using SAS in clinical trials data analyses.
    • Exposure to CDISC (SDTM and ADaM) is a plus.

    SKILLS:

    • Expertise in SAS/BASE, SAS/STAT, SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS.
    • Knowledge of SDTM, ADaM, FDA and ICH guidance.
    • Understanding of Code of Federal Regulations (CFR) Title 21, Part 11.
    • Strong organizational and time management skills.
    • Consistent experience as a lead statistical programmer.
    • Excellent analytical and presentation skills.
    • Proven ability to learn new systems and function in an evolving technical environment.
    • Ability to negotiate, influence, and create strategies to improve efficiency.
    • Business awareness and financial acumen.
    • Ability to work effectively in a quality-focused environment.