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.
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.
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.
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