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    Senior Statistical Programmer

    Parexel
    7+ years
    Preferred by Comapny
    Hyderabad
    12 Nov. 25, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Statistical Programming Lead

    Job Description:

    We are seeking a Statistical Programming Lead to take ownership of statistical programming tasks across assigned projects. This position requires strong expertise in statistical programming, project management, and the ability to lead teams in delivering high-quality results within timelines and budgets. The role offers the opportunity to work with sponsors, internal teams, and stakeholders to provide high-level statistical programming support across clinical trials.

    Key Accountabilities:

    1. Project Management:

    • Lead Statistical Programming efforts on projects, ensuring timelines and budget adherence.
    • Coordinate project start-up activities, creation of global programs, and documentation for statistical programming.
    • Monitor project resources, project budgets, and scope changes, ensuring timely execution of tasks.
    • Interact with sponsors and internal stakeholders regarding statistical programming issues, providing solutions for any problems encountered.
    • Review statistical analysis plans and mock-shells, ensuring clarity and consistency.
    • Oversee database set-up specifications to align with project needs.
    • Assist project teams in resolving day-to-day challenges encountered in their work.

    2. Statistical Programming for Assigned Projects:

    • Deliver high-quality and value-driven statistical programming services.
    • QC your own work continuously to ensure first-time quality in all datasets (e.g., SDTM, ADaM), tables, figures, and data listings.
    • Produce and QC supporting documentation like dataset specifications, submission documents, and process documentation.
    • Ensure adherence to corporate quality standards, SOPs, ICH-GCP, and international regulations.
    • Perform quality control (QC) on derived datasets, tables, and figures to meet technical and regulatory standards.

    3. Training:

    • Stay up-to-date with local and international regulatory knowledge within the clinical industry.
    • Mentor and train staff and project teams on statistical programming practices and systems.
    • Expand expertise in SAS and processes across PAREXEL's functional areas.

    4. General Responsibilities:

    • Maintain all study documentation in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
    • Ensure compliance with SOPs, ICH-GCP, and local and international regulations (e.g., 21 CFR Part 11, electronic submissions).
    • Participate in audits and regulatory inspections as required.
    • Lead process/quality improvement initiatives to ensure continued optimization.
    • Provide consultancy to sponsors on statistical programming tasks.
    • Represent PAREXEL at sponsor marketing and technical meetings.

    5. Skills:

    • Excellent analytical skills and proficiency in SAS.
    • Strong project management and organizational skills, with the ability to manage competing priorities.
    • Detailed understanding of the programming and reporting process.
    • Knowledge of SOPs/Guidelines, ICH-GCP, and regulations like 21 CFR Part 11 and electronic submissions.
    • Ability to learn new systems and adapt to evolving technical environments.
    • Strong attention to detail and ability to lead a global team effectively.
    • Excellent communication skills, both written and verbal.

    6. Education:

    • Educated to degree level in a relevant discipline (e.g., Statistics, Life Sciences) or equivalent work experience.

    This role is ideal for individuals looking to leverage their experience in statistical programming and project management to lead teams, manage projects efficiently, and contribute to high-quality clinical trials. Strong communication skills and a customer-focused mindset are essential for success in this position.

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