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    Senior Statistical Programmer Ii

    Novotech
    7+ 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: We are seeking an experienced Clinical Statistical Programmer to join our team at Novotech. This role involves overseeing SAS programming activities for clinical studies, leading a programming team, and ensuring compliance with industry standards and regulations.

    Minimum Qualifications & Experience:

    • Bachelor's degree in Life Sciences, Computer Science, Mathematics, Statistics, or a related quantitative/analytical field.
    • A minimum of 7 years of experience in the pharmaceutical industry, CRO, or a similar environment, with extensive experience using SAS programming in clinical studies.
    • Proven ability to lead clinical study or project programming teams.
    • Exceptional SAS programming skills.
    • Knowledge of CDISC standards and their application across various study phases, designs, and therapeutic areas.

    Key Responsibilities:

    1. Projects/Clinical Studies:

      • Review clinical study protocols with respect to statistical programming responsibilities.
      • Assess study-related workloads and project timelines. Collaborate with the Statistical Programming Team Lead to discuss programming time estimates and risk mitigation plans.
      • Review and provide input on Statistical Analysis Plans (SAPs) related to data presentation (tables, listings, figures).
      • Develop and maintain SDTM and ADaM dataset specifications for assigned projects.
      • Perform peer reviews of SDTM and ADaM dataset specifications created by junior staff.
      • Program SDTM and ADaM datasets, tables, figures, and listings according to approved specifications.
      • Ensure adherence to company programming standards, data standards, and documentation practices.
      • Assess and discuss requests for changes to SAP, tables, listings, figures, and datasets with the Statistical Programming Team Lead.
      • Participate in audits and represent Novotech at client meetings as required.

    2. Clinical Product Development:

      • Conduct gap analysis of clinical study databases for standardization and transformation needs.
      • Develop project plans and cost estimates in consultation with the Line Manager and Biostatistics team.
      • Create programs for generating SDTM datasets, SDTM annotated CRFs, ADaM datasets, Define.xml datasets, Reviewers Guides, and other regulatory documents.

    3. Team and Collaboration:

      • Participate in Statistical Programming section meetings, Biostatistics meetings, and Biometrics department meetings.
      • Mentor junior staff in technical matters and assist with their induction.

    4. Software and Programming Tools:

      • Contribute to the development of company programming conventions and SAS macros.
      • Assess the impact of new software releases and patches on ongoing projects.
      • Assist in automating statistical programming tasks and progress tracking.
      • Advise Clinical Data Management and Clinical Data Programming teams on CRF libraries and data dictionaries based on CDASH and SDTM.

    5. Statistical Programming Processes and SOPs:

      • Contribute to the development and updating of SOPs, best practices, and quality control measures related to statistical programming.
      • Ensure compliance with regulatory guidelines and Novotech’s corporate policies and SOPs for study design, protocol development, and statistical programming outputs.

    About Novotech: Novotech operates in 11 regions and maintains partnerships with key medical institutions. As a leading Asia-Pacific biotech specialist CRO, we provide 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 holds ISO 27001 and ISO 9001 certifications, ensuring 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. With over 3,700 clinical projects spanning Phase I to IV trials and bioequivalence studies, we are positioned to support biopharmaceutical clients conducting trials in Asia and 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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