Proprietor at ApicalGo Consultancy
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Senior Biostatistician - CRO/Pharma Domain (4-7 yrs)
LOCATION: PAN INDIA / WFH
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.
- Collaborates with clinical investigators to determine study design.
- Writes sections of protocols that require statistical input.
- Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained.
- Generates treatment allocations in randomized clinical research studies and ensures proper implementation.
- Leads the project team's development of statistical analysis plans and programs to perform analyses and display study data.
- Performs statistical analyses, writes and validates application programs.
- Implements 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.
- Applies, guides and ensures others on team are implementing QC processes, ensuring deliverables are accurate, are of high quality and delivered on agreed timelines.
- Authors or contributes to manuscripts and/or scientific presentations.
- Participates in professional development activities both within and outside the company.
- Ensure timely and effective communication of project milestones and status to internal stakeholders.
- Assists the cross functional communication for smooth deliverables of study related documents.
- Works with multi-disciplinary teams
- Requires a Master's or PhD degree in Statistics with minimum of 4 - 7 years of clinical research experience.
- Solid understanding of design of experiments; Demonstrated proficiency with statistical methods and applications in clinical research.
- Competent in SAS programming language and/or R.
- Expertise in state-of-the-art data manipulation and statistical methodology.
- Ability to manage multiple tasks.
- Ability to work independently, as well as in a team environment.
- Ability to effectively communicate technical concepts, both written and oral.
- Ability to lead / drive departmental initiatives (with Supervision).