Digambar Salunkhe

About Digambar Salunkhe

Biostatistician with over 8 years of experience of working in various clinical trial phases (Phase I to Phase IV) and BA/BE studies. Expertise in developing & reviewing Statistical Analysis Plan (SAP), mock shells in accordance with study protocols, developing Statistical Analysis Report (SAR), preparing Interim Analysis Plan (IAP), CSDAP and ISS plan in accordance with study requirement. Having a good knowledge of various statistical methodologies and perform statistical review of efficacy, PK and safety tables, listings and figures (TLFs). Basic knowledge of Sample size estimation and justification and Generation of randomization schedule. Having good exposure in reviewing SAS datasets and eCRF. Involved in review of Clinical Study Report (CSR). Knowledge of applicable clinical research regulatory requirements, i.e, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and FDA guidelines. Ability to establish and maintain effective working relationships with co-workers, managers, and clients. Providing training and guidance to Juniors and new staffs. Led and supported preparation of Request for Proposals (RFP). Therapeutic Areas: Ophthalmology, Oncology, Dermatology, Pain Management, Urology and Renal disease.

Experience

1. Senior Biostatistician i

   ICON plc

   Nov 2024 — Present

Education

• Saradar Patel University

  Master of Science (M.Sc.), Biostatistics

  2014 — 2016