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    Statistical Programmer I

    Novotech
    2+ years
    Not Disclosed
    India
    10 Sept. 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 Description

    Position Overview: The Clinical Data Programmer at Novotech plays a crucial role in the Data Management department, focusing on programming activities related to clinical trials. This position involves developing and maintaining SDTM and ADaM datasets, ensuring adherence to company and regulatory standards, and contributing to various programming tasks and meetings.

    Minimum Qualifications & Experience:

    • Bachelor’s Degree in Life Sciences, Computer Science, Mathematics, Statistics, or a related quantitative/analytical field.
    • Basic knowledge of Base SAS.
    • Strong organizational and communication skills.
    • Ability to work independently while maintaining effective relationships with co-workers, managers, and clients.

    Responsibilities:

    • Dataset Development:

      • Develop and maintain specifications for SDTM and ADaM or analysis datasets for assigned projects.
      • Program SDTMs, ADaMs, and other analysis datasets, tables, figures, and listings (TFLs) in line with approved specifications.
      • Ensure SAS programs used for data storage, transformation, presentation, and statistical analysis are well-documented and traceable.

    • Compliance and Standards:

      • Adhere to company standards and conventions for statistical programming and data management.
      • Ensure compliance with applicable regulatory guidelines, Novotech’s corporate policies, and SOPs for study design, protocol development, and statistical programming outputs.

    • Documentation and Reporting:

      • Maintain study documentation, programming files, and timesheets within project files.
      • Participate in Statistical Programming section meetings, Biostatistics meetings, and Biometrics department meetings.

    • Skills Development:

      • Acquire proficiency in all relevant statistical programming software and company standards and conventions.

    About Us: Novotech operates across 11 regions and partners with key medical institutions. As a leading Asia-Pacific biotech specialist CRO, we offer comprehensive clinical development services across all trial phases and therapeutic areas. Our services include feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, and more. Novotech is ISO 27001 and ISO 9001 certified, demonstrating our commitment to the highest IT security and quality standards.

    About the Team: Novotech, including its operating brands Novotech and PPC, has extensive experience in clinical trials and biotech. We have managed over 3,700 clinical projects, from Phase I to IV trials and bioequivalence studies, positioning us to support biopharmaceutical clients globally. As of September 30, 2021, Novotech employed over 2,750 FTEs across Asia-Pacific, the United States, and the UK.

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