Job Description

Designation : Biostatistician Experience: 4+ years CTC : 10-12 LPA Location : Chandigarh / WHO ( there will be requirement to come to the office as and when needed, maybe once in 6 months or 1 year (not frequent). Primary Purpose: The Biostatistician collaborates with clinical investigators to determine study design, contributes to protocol development, writes statistical analysis plans, performs statistical analysis and inference and writes and presents reports summarizing findings including publications in peer reviewed journals. The Biostatistician develops systems for monitoring the quality of clinical data. The Biostatistician ensures high-quality statistical support is provided for clinical trials, registries and basic research using advanced statistical skills and knowledge of clinical research. The Biostatistician maintains expertise in state-of-the-art data manipulation and statistical methodology. Responsibilities : Specific responsibility would involve the below: Provide statistical reasoning behind clinical studies, Develop sample size needs & estimates for proving or disproving hypothesis. Uses computer programs to gather, analyze, and track data about biological functions in order to gain a better understanding of biological activities. Collaborates with clinical investigators to determine study design. Creates statistical text for study concept documents and protocols (study design, endpoints, sample size, methods for analysis). Utilizing appropriate software, writes and completes programming and scientific analysis of data sets, tables, graphs and lists for protocol/study reports, product registration documents and publications. Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained. Should be able to provide/generate treatment allocations in randomized clinical research studies and ensures proper implementation. Must be able to implement data and safety monitoring reports to ensure participants safety. Develops metrics and generates quality control reports to optimize the performance of clinical sites and the coordinating center. Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies. Should assist in completing high quality deliverables on agreed timelines. Authors or contributes to manuscripts and/or scientific presentations. Ensure timely and effective communication of project related information within team; works with multi-disciplinary teams. Assists the cross functional requirement for smooth deliverables of study related documents. Qualification and Experience MSc in Statistics. Minimum 2+ years of Clinical Trial Statistician experience, having relevant knowledge in clinical trial biostatistics to support in design, analysis, and interpretation. Strong Knowledge in survival analysis, linear and generalized linear models. Capacity to interface effectively with clinicians and statistical programmers. To understand the statistical methodology and apply it to clinical data. Ability to work complying with the company Analysis and Reporting SOPs and project data standards. Excellent analytic and critical thinking skills, writing skills, communication skills, consulting skills, and ability to work within a team. Fast learner, team-oriented, able to work independently.

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