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    Principal Statistical Programmer

    Parexel
    2+ years
    Not Disclosed
    Remote
    10 Dec. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Department: Statistical Programming
    Location: Remote

    About Parexel:

    As a member of Parexel’s Statistical Programming group, you will be integral in analyzing, summarizing, and presenting clinical data to evaluate the safety and efficacy of clinical trials. You will be working across different therapeutic areas, engaging with varied data entries and endpoints in a dynamic environment. At Parexel, we foster a culture of growth with extensive training, mentoring, and knowledge sharing.

    You will collaborate closely with both clients and Parexel teams to maximize the collective strength of our workforce. Our inclusive workplace offers a supportive and motivating environment that promotes teamwork, innovation, and excellence in clinical trials.

    Success Profile:

    We are looking for individuals with the following soft skills and interpersonal traits to succeed in this role:

    • Analytical
    • Detail-oriented
    • Independent
    • Proactive
    • Responsible
    • Team-player

    Key Accountabilities:

    Project Management:

    • Lead Statistical Programming Projects: Coordinate and lead the statistical programming team to ensure timely and successful study completion, while staying within the given timelines and budget.
    • Timeline & Resource Management: Input into and negotiate programming timelines, monitor project resourcing, budgets, and manage any scope changes.
    • Coordinate Project Start-Up Activities: Create global programs, tracking spreadsheets, and documentation to kick-start projects.
    • Stakeholder Management: Interact with sponsors and internal stakeholders to address statistical programming issues and ensure smooth project execution.
    • Resolve Issues: Assist project teams in overcoming obstacles encountered during daily work processes.

    Statistical Programming for Assigned Projects:

    • Data Processing & QC: Deliver high-quality statistical programming services, using efficient techniques to produce/QC derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings.
    • Documentation: Produce specifications, process documents, and submission documentation in accordance with corporate quality standards, SOPs/Guidelines, and regulatory requirements (ICH-GCP, etc.).
    • Quality Control: Ensure QC is performed on all aspects of derived datasets, tables, listings, and figures.

    Training & Knowledge Sharing:

    • Expand Regulatory Knowledge: Keep updated on local and international regulatory standards and provide relevant training on clinical data management systems, safety reporting, SAS, and more.
    • Mentorship: Lead knowledge sharing forums, mentor staff, and support the wider department's development.

    General Responsibilities:

    • Regulatory Compliance: Maintain supporting documentation for studies and ensure compliance with SOPs, ICH-GCP, and applicable local/international regulations.
    • Process Improvement: Lead or participate in initiatives to improve quality, efficiency, and productivity across statistical programming processes.
    • Consultancy: Provide consultancy on statistical programming tasks to internal and external stakeholders.

    Skills & Qualifications:

    Key Skills:

    • SAS Programming Expertise: Advanced knowledge of SAS programming techniques, including data manipulation and reporting.
    • Analytical Proficiency: Excellent analytical and problem-solving skills, particularly related to clinical data and reporting processes.
    • Project Management: Strong organizational skills, the ability to manage competing priorities, and the flexibility to adapt to changes.
    • Quality & Attention to Detail: Commitment to delivering high-quality work and attention to detail in all tasks.
    • Leadership: Ability to lead, mentor, and guide a global team in a statistical programming environment.
    • Client-Focused: Strong customer focus with excellent communication and negotiation skills.

    Experience:

    • Proven experience leading statistical programming teams and delivering on clinical trial analysis and reporting.
    • Familiarity with regulations such as 21 CFR Part 11, CDISC, and other industry standards for clinical data.

    Educational Qualifications:

    • Degree in a relevant discipline (e.g., Statistics, Mathematics, or a related field) or equivalent work experience in statistical programming and clinical trials.

    Additional Information:

    • Remote Work: This role is open to remote work, allowing flexibility and collaboration across different geographical locations.

    If you are looking for an exciting and dynamic opportunity in statistical programming and want to work with a leading global team, apply now to join Parexel and contribute to the advancement of clinical trials.

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