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    Lead, Statistical Programming

    Biorasi
    3+ years
    Not Disclosed
    Remote, USA
    10 Dec. 11, 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 Programmer
    Location: Remote (Global)
    Employment Type: Full-time
    Posted: 12/11/2024

    About Biorasi:

    At Biorasi, we are rapidly expanding, offering a collaborative, dynamic, and evolving environment. As an award-winning, customer-focused, full-service clinical research organization, we support your career growth while promoting work-life balance. We're seeking passionate individuals to join our team, whether you're an industry veteran or new to clinical research. This is your chance to be part of a global company driving new therapies to patients in an expanding industry.

    Your Role:

    As a Statistical Programmer, you will play a key role in ensuring the accuracy, timeliness, and quality of statistical programming deliverables. Your responsibilities will include:

    • Ensuring outputs meet quality standards and project requirements.
    • Organizing and maintaining up-to-date project documentation to ensure inspection readiness.
    • Reviewing study documents (Protocol, eCRF, Dataset specifications, SAP) and providing feedback.
    • Developing and maintaining standard programs, macros, templates, and libraries for statistical programming activities.
    • Contributing to project-specific objectives and team deliverables.
    • Managing on-time delivery of concurrent programming tasks.
    • Resolving complex statistical programming challenges and providing guidance to teams.
    • Developing annotated CRFs, regulatory submission documentation, Define.xml, and data reviewer’s guides.
    • Developing programming specifications that comply with client requirements, CDISC standards, and statistical outputs (datasets, tables, listings, figures).
    • Creating and validating CDISC-compliant datasets (SDTM/ADaM) and TLFs supporting clinical study reports, regulatory submissions, and publications.
    • Serving as a back-up primary contact for sponsors, vendors, and project teams regarding study programming activities.
    • Reviewing and approving eCRFs as necessary.
    • Leading small internal/consultant programming teams.
    • Maintaining professionalism, performance, and high-quality standards.
    • Undergoing regulatory training, including ICH GCP and 21 CFR Part 11.

    Your Profile:

    • Education: Bachelor’s Degree in Mathematics/Statistics, Life Sciences, Computer Science, or related field, or equivalent experience.
    • Experience: At least 3 years in Biostatistics or Statistical Programming within the pharmaceutical industry or a related field.
    • Skills:
      • Experience in planning, coordinating programming activities, and leading programming teams is preferred.
      • Strong attention to detail, timeliness, and quality.
      • Excellent problem-solving, leadership, and communication skills.
      • Ability to multitask, prioritize, and work in a fast-paced environment.
      • Significant knowledge of drug development, clinical research, and applicable regulatory requirements (ICH GCP, 21 CFR Part 11).
      • Strong team collaboration skills with cross-functional teams.

    Why Biorasi?

    • Employee Benefits: Half-day Fridays, paid time off, holidays, employee bonus programs, career growth, and training opportunities.
    • Diversity and Inclusion: Biorasi is committed to creating a diverse environment and is an equal opportunity employer. We celebrate diversity and ensure fair employment practices.

    Apply Now:

    If you're ready to join an energetic, creative, and collaborative team, apply directly on our website at Biorasi Careers or email us at careers@biorasi.com.

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