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    Statistical Programmer Ii

    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 Programmer

    Department: Statistical Programming
    Location: Remote

    About Parexel:

    As a Statistical Programmer at Parexel, you will play a crucial role in analyzing, summarizing, and presenting clinical data to assess the safety and efficacy of clinical trials. Your work will directly impact the speed at which new treatments reach patients. The role requires precision, attention to detail, and the ability to communicate complex data clearly. Working across various therapeutic areas, you will help assess different data entries and endpoints in a dynamic and evolving environment. Parexel provides a collaborative, supportive, and motivating work atmosphere, with ample opportunities for growth, mentoring, and skill development.

    Success Profile:

    We are looking for individuals who have the following soft skills and interpersonal traits to thrive in this role:

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

    Key Responsibilities:

    Project Management:

    • Support Start-up Activities: Assist in the coordination of project start-up activities, including the creation of global programs, tracking spreadsheets, and other required documentation.

    Statistical Programming for Assigned Projects:

    • Deliver High-Quality Service: Provide exceptional statistical programming services by producing derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings of varying complexity.
    • QC and Documentation: Quality check low- to medium-complexity datasets, tables, figures, and listings. Assist in the production and QC of derived dataset specifications and other supporting documentation.

    Training & Knowledge Development:

    • Expand Knowledge: Continuously update your understanding of local and international regulatory requirements, clinical industry trends, and SAS programming.
    • Training & Mentorship: Provide training and mentorship to junior staff and project teams as needed.

    General Responsibilities:

    • Ensure Compliance: Maintain supporting documentation for clinical studies to ensure traceability and adherence to SOPs, ICH-GCP, and applicable regulations (e.g., 21 CFR Part 11).
    • Contribute to Quality Improvement: Actively participate in process and quality improvement initiatives and ensure compliance with industry technical standards (e.g., CDISC).

    Collaboration & Communication:

    • Teamwork: Work closely with global teams, ensuring effective collaboration to achieve project goals.
    • Client Interaction: Support project teams and liaise with clients to meet deadlines and exceed expectations.

    Skills & Qualifications:

    Core Skills:

    • Analytical Skills: Strong analytical abilities with a keen eye for detail.
    • Proficiency in SAS: Expertise in SAS programming techniques, used to produce statistical outputs and datasets.
    • Regulatory Knowledge: Knowledge of industry standards such as CDISC, ICH-GCP, and 21 CFR Part 11.
    • Communication: Excellent written and verbal communication skills, with the ability to convey complex statistical concepts clearly.

    Additional Skills:

    • Adaptability: Ability to learn new systems and adapt to an evolving technical environment.
    • Time Management: Effective time management skills to meet daily objectives and deadlines.
    • Global Teamwork: Ability to collaborate successfully within global teams and work effectively in a quality-focused environment.

    Education & Experience:

    • Degree Level Education: A degree in a relevant discipline or equivalent work experience in statistical programming or clinical data analysis.
    • Experience: Some prior experience in statistical programming and clinical trials is advantageous.

    Additional Information:

    • Remote Work: This position is remote, offering flexibility and the opportunity to collaborate with a global team.
    • Growth Opportunities: Parexel offers extensive training and career development opportunities, fostering both personal and professional growth.

    If you have a passion for data analysis and want to make a meaningful impact in clinical trials, apply today to join Parexel and help bring life-changing treatments to patients faster.

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