Sr Biostatistician
Genzyme
Karachi
10d ago

The Biostatistician will provide support to medical affairs and clinical operations team in study designing, data analysis and reporting of clinical research projects.

Study Management :

  • Provide statistical support to medical affairs team and independently manage all statistical aspects of clinical research project
  • Assist medical affairs in designing research studies (Observational and Interventional)
  • Provide assistance in development of study synopsis (SO) and sample size calculations
  • Review clinical research protocols / SOs (local and regional) during Study Review Committees and recommend appropriate statistical analyses.
  • Write detailed statistical sections in protocols and simultaneously develop Statistical Analysis Plan (SAP) for local studies
  • Track and record approvals of local synopsis, protocols, protocols amendments and Clinical Study Reports (CSRs)
  • Develop program in EPI data software for capturing data electronically and ensure timely data entry for local studies.
  • Ensure accuracy and validity of the data.

  • Identify data queries and prepare data resolution form (DRFs)
  • Liaise with Clinical Research Associates for timely retrieval of Case Report Forms (CRFs) and DRFs.
  • Analyze clinical data using appropriate statistical approaches and develop clinical study report (CSR)
  • Liaise with Medical Managers & CRA throughout study period and ensure timely update of Clinical Trail Management System (CTMS).
  • Perform monthly review of CTMS report and ensure compliance rate.

  • Interact with regional Clinical Study Unit team for relevant matters.
  • Ensure timely and systematic data management / archiving.
  • Publications :

  • Provide assistance in publication writing e.g abstracts, posters, presentations & Manuscripts
  • Coordinate with medical journals for publications and facilitate authors in preparing responses for reviewer’s comments.
  • Additional responsibilities :

  • Develop relevant Standard Operational Procedure (SOP) documents
  • Liaisetransversally with other departments and assist in data analysis of their pertinent data sets.
  • Participate in special projects to improve processes, tools, systems and organization
  • Provide trainings on Basic principles of Biostatistics and Epidemiology.
  • Education :

  • Masters in Biostatistics
  • Experience & Knowledge :

  • Minimum 3-5-year experience as a statistician in clinical research
  • Core competencies : Effective verbal, written communication and inter-personal skills. Proficient in MS. Office, SPSS, Manitab, STATA and Epi data.

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.

    We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-

    term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

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