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    Lead, Statistical Programming

    Biorasi
    3+ years
    Not Disclosed
    Remote, USA
    10 Sept. 30, 2024
    Job Description
    Job Type: Remote 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

    Join Our Growing Team at Biorasi!

    At Biorasi, we’re dedicated to supporting your career journey in an innovative, collaborative, and dynamic environment. As an award-winning, customer-focused full-service clinical research organization, we harness your strengths while promoting a healthy work-life balance.

    We’re seeking top performers who are as passionate about clinical research as we are—whether you’re a seasoned clinical trial veteran or a newcomer ready to thrive in our fast-paced environment. Here’s your chance to be an integral part of a global company that’s making a difference in the clinical research industry.

    Your Role:

    • Quality Assurance: Ensure all outputs meet quality standards and project requirements.
    • Documentation Management: Guide and maintain organized, up-to-date project documentation, ensuring inspection readiness.
    • Study Document Review: Read and understand study documents (Protocols, eCRFs, Dataset specifications, SAP, Mock shells) and provide constructive feedback.
    • Programming Development: Create and maintain standard programs, macros, templates, and libraries for statistical programming activities.
    • Project Contribution: Collaborate on project-specific objectives and deliverables.
    • Timely Delivery: Ensure on-time delivery across concurrent programming tasks.
    • Problem Resolution: Address complex statistical programming challenges and offer guidance to teams.
    • Documentation for Regulatory Submissions: Develop annotated CRFs and regulatory submission documentation, including Define.xml and data reviewer’s guides.
    • Client Compliance: Create programming specifications based on client requirements, ensuring compliance with CDISC standards for datasets, tables, listings, and figures.
    • Dataset Development: Develop and validate CDISC-compliant datasets (SDTM/ADaM) and Tables, Listings, and Figures (TLFs) using programming specifications and the SAP.
    • Team Leadership: Act as a backup contact for sponsors, vendors, and project teams regarding programming activities.
    • eCRF Review: Review and approve electronic Case Report Forms (eCRFs) as necessary.
    • Team Coordination: Lead small teams of internal and consultant programmers to advance programming deliverables.
    • Professionalism and Quality: Maintain a high level of professionalism, performance, and quality in all tasks.
    • Regulatory Training: Undergo training in regulations such as ICH GCP and 21 CFR Part 11.
    • Additional Duties: Perform other statistical programming responsibilities as assigned.

    Your Profile:

    • Education: Bachelor’s Degree in Mathematics, Statistics, Life Sciences, Computer Science, or a related field, or equivalent experience.
    • Language Skills: Fluent in English (oral and written).
    • Experience: At least 3 years in Biostatistics or Statistical Programming within the pharmaceutical industry or a related field. Experience in planning and coordinating programming activities is preferred.
    • Multitasking: Ability to manage multiple tasks and prioritize effectively.
    • Attention to Detail: Strong focus on detail, timeliness, and quality.
    • Problem-Solving: Excellent problem-solving and leadership skills with a knack for developing creative, practical solutions.
    • Team Collaboration: Strong team player with experience working in cross-functional teams.
    • Industry Knowledge: Significant understanding of drug development and clinical research.
    • Regulatory Knowledge: Good knowledge of ICH GCP and applicable global regulatory requirements.
    • Fast-Paced Adaptability: Ability to thrive in a fast-paced environment.
    • Communication Skills: Exceptional time management, planning, and communication skills (both written and verbal).

    If you have the required experience and want to join a vibrant, creative, and collaborative team, please apply directly on our website at Biorasi Careers or email us at careers@biorasi.com.

    Employee Benefits:

    We prioritize the well-being of our employees and their families by offering thoughtfully designed benefits, including half-day Fridays, paid time off, paid holidays, country-specific benefits, employee bonus programs, and opportunities for career growth and development.

    Our Commitment to Diversity:

    Biorasi is committed to creating a diverse and inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We also uphold fair employment practices regarding citizenship and immigration status.

    Join us in shaping the future of clinical research!

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