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Sumit Kandale
Manager – Biostatistics & Clinical Data Management
Manager – Biostatistics & Clinical Data Management
Sumit Kandale is a Biostatistics and Clinical Data Management professional with over 9 years of experience in clinical analytics, bioequivalence, and pharmacokinetic studies. He specializes in Statistical Analysis Plan (SAP) development, regulatory-compliant statistical reporting, and leading cross-functional teams across biostatistics and CDM functions. Proficient in SAS, R, and Phoenix WinNonlin, Sumit has deep expertise in CDISC standards (SDTM/ADaM), sample size estimation, randomization, and BE/BA statistical evaluation. Known for driving audit-ready deliverables and process improvement initiatives, he collaborates effectively with sponsors and regulatory agencies while ensuring data quality, integrity, and compliance with FDA, EMA, and ICH guidelines.
FORMERLY AT
Accutest Research Laboratory Pvt. Ltd.
LOCATION
Mumbai
AVAILABILITY
Full Time
Skills
Academic software
MS Excel
MS Office
Phoenix WinNonlin
R
SAS
SAS (v9.4)
SDTM/ADaM
Statistical analysis tools
Work Experience
Manager – Biostatistics & Clinical Data Management
Accutest Research Laboratory Pvt. Ltd.
March 2025 – Present
- Lead cross-functional teams of biostatisticians and CDM professionals across multiple clinical projects.
- Oversee protocol design, sample size estimation, SAP creation, and statistical deliverables.
- Act as the primary liaison with sponsors and regulatory authorities, ensuring audit readiness and compliance.
- Supervise SDTM/ADaM programming teams and drive process improvements within the department.
TECHNOLOGIES
SAS (v9.4), Phoenix WinNonlin, R, SDTM/ADaM, MS Office
Biostatistician
Synapse Labs Pvt. Ltd.
January 2016 – October 2024
- Prepared SAPs, annotated CRFs, randomization schedules, and statistical specifications.
- Conducted bioequivalence and pharmacokinetic analyses using SAS and Phoenix WinNonlin.
- Created SDTM datasets and validated outputs for regulatory submissions.
- Trained team members, supported US-FDA/EMA/sponsor audits, and contributed to SOP and process optimization.
TECHNOLOGIES
SAS, Phoenix WinNonlin, SDTM/ADaM, MS Excel
Lecturer – Statistics
Vidya Pratishthan’s College of Science & Commerce
Aug 2010 – Jan 2016
- Taught undergraduate courses in Statistics, Business Analytics, Numerical Methods, and Data Interpretation.
- Conducted lab sessions, mentored students, and managed academic administrative activities.
- Held additional roles including Director of Sports and event coordinator.
TECHNOLOGIES
Statistical analysis tools, Academic software, MS Office
