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Sumedh Tiwari
Biostatistics Manager
Biostatistics Manager
Sumedh Tiwari is a Biostatistics Manager with 9 years of experience in clinical, pharmaceutical, and public health research. He specializes in study design, SAP development, statistical modeling, and CDISC-compliant dataset creation (SDTM/ADaM). Proficient in SAS, SPSS, STATA, and CSPro, Sumedha leads end-to-end statistical planning and analysis for BE/BA and epidemiological studies, including pharmacokinetic evaluations. He has managed large-scale national research projects, developed CRFs and statistical frameworks, and collaborated with cross-functional clinical and research teams to ensure data integrity and regulatory compliance. Known for analytical problem-solving and effective stakeholder communication, He consistently delivers high-quality, reproducible statistical outputs.
FORMERLY AT
Sun Pharmaceuticals Ltd.
LOCATION
Mumbai
AVAILABILITY
Full Time
Skills
ADaM
CDISC (SDTM
CSPro
Excel
SAS
SPSS
STATA
Work Experience
Biostatistics Manager
Sun Pharmaceuticals Ltd.
May 2021 – Present
- Lead statistical planning, SAP development, and regulatory-compliant analysis for BE/BA studies.
- Conduct pharmacokinetic and analytical equivalence statistical evaluations.
- Develop and validate randomization schemes and CDISC SDTM/ADaM datasets.
- Provide statistical inputs for protocols, sample size estimation, and responses to regulatory queries.
- Collaborate with cross-functional stakeholders including PK experts, formulation scientists, and protocol managers to ensure data accuracy and integrity.
TECHNOLOGIES
SAS, SPSS, STATA, CDISC (SDTM, ADaM)
Freelance Biostatistician
Self-employed
August 2019 – April 2021
- Provided end-to-end statistical support for research studies, including data analysis and interpretation.
- Delivered SAPs, statistical outputs, and publication-ready reports. Advised clinical and academic researchers on study design and inferential statistics.
TECHNOLOGIES
SAS, SPSS, STATA
Consultant – Biostatistics
ICMR – National Institute of Medical Statistics (NIMS)
October 2015 – May 2018
- Supported large-scale epidemiological and observational studies.
- Designed CRFs, statistical analysis plans, and data collection tools.
- Managed nationwide datasets and prepared statistical summaries, fact sheets, and reports.
- Contributed to national disease burden estimation and scientific manuscripts.
TECHNOLOGIES
CSPro, SAS, SPSS
Statistical Assistant (Research)
ICMR – National Institute of Research for Tribal Health (NIRTH)
October 2012 – October 2015
- Performed statistical design and analysis for field-based clinical and public health projects.
- Developed survey tools, analysis plans, and research reports.
- Supported data collection activities and ensured data quality.
TECHNOLOGIES
SPSS, Excel, SAS
