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    Senior Statistical Programmer

    Parexel
    0 -1 yrs. in PV / 1-2 yrs. in clinical practice years
    Preffered by Company
    Remote
    15 July 11, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D, Nursing Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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 Title: Senior Statistical Programmer

     

    Location: Remote (India)
    Additional Locations: Hyderabad, Chandigarh, Mohali, Bengaluru, Mumbai

    Time Type: Full Time
    Posted On: Posted 9 Days Ago
    Job Requisition ID: R0000024432

     

    Overview

    At Parexel, our shared goal is to improve the world's health. Every clinical development solution we provide, from clinical trials to regulatory consulting and market access, is driven by our deep conviction in what we do. Each team member, regardless of their role, contributes to the development of therapies that ultimately benefit patients. We approach our work with empathy and are committed to making a difference.

     

    Key Accountabilities

    Project Management:

    • Serve as Statistical Programming Lead on projects.
    • Input into and negotiate statistical programming timelines, ensuring adherence.
    • Coordinate and lead a statistical programming team to complete studies within given timelines and budget.
    • Monitor project resourcing, project budgets, and identify changes in scope.
    • Coordinate project start-up activities, including the creation of global programs, tracking spreadsheets, and required documentation.
    • Review statistical analysis plans and mock-shells.
    • Review database set-up specifications.
    • Interact with sponsors and internal stakeholders regarding statistical programming issues.
    • Assist project teams in resolving problems encountered during their work.

     

    Statistical Programming for Assigned Projects:

    • Deliver high-quality service and value.
    • Perform ongoing quality checks on your work to ensure first-time quality.
    • Use efficient programming techniques to produce/QC derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings.
    • Experience with PROC Report and complex SAS Graph programming.
    • Produce/QC complex ADaM dataset specifications and other process-supporting documents and submission documentation.
    • Ensure quality control (QC) on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and other international regulatory requirements.

     

    Training:

    • Maintain and expand local and international regulatory knowledge within the clinical industry.
    • Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas.
    • Provide relevant training and mentorship to staff and project teams.

     

    General:

    • Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
    • Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations.
    • Participate in internal/external audits and regulatory inspections as required.
    • Proactively participate in and/or lead process/quality improvement initiatives.
    • Provide consultancy to internal and external sponsors regarding statistical programming tasks.
    • Represent PAREXEL at sponsor marketing and technical meetings.
    • Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, and electronic submissions).

     

    Skills

    • Excellent analytical skills.
    • Proficiency in SAS.
    • Experience with PROC Report and complex SAS Graph programming.
    • Extensive knowledge and understanding of the programming and reporting process.
    • Knowledge of SOPs/Guidelines, ICH-GCP, and other applicable regulations such as 21 CFR Part 11.
    • Ability to learn new systems and adapt to evolving technical environments.
    • Strong project management and organizational skills.
    • Attention to detail and ability to manage competing priorities.
    • Ability to lead a global team effectively.
    • Effective time management to meet daily metrics or team objectives.
    • Commitment to performing consistently high-quality work.
    • Business/operational skills, including customer focus, commitment to quality management, and problem-solving.
    • Commitment to refining quality processes.
    • Good presentation and business awareness/development skills (including financial awareness).

     

    Knowledge and Experience

    • Competent in written and oral English.
    • Excellent communication skills.

     

    Education

    • Educated to degree level in a relevant lifesciences discipline and/or equivalent work experience.

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