Hemant Mahale

About Hemant Mahale

At Pfizer, our team leverages statistical programming skills to develop and validate datasets and tables following CDISC standards for clinical trial phases, ensuring efficient FDA submissions. With a foundation in Statistics from North Maharashtra University, I have honed competencies in SAS and R, contributing significantly to programming deliverables, QC plans, Validation on end to end activities.Collaboration is key in our pursuit of excellence; we integrate client feedback, working closely with standards teams to tailor code and validate submissions. My role as a Statistical Programmer showcases a commitment to quality and continuous learning, as evidenced by ongoing engagement in AI/ML advancements and knowledge-sharing sessions.

Experience

1. Statistical Programmer Ii

   IQVIA

   Apr 2025 — Present · IN

   As a Statistical Programmer II in IQVIA, I specialize in delivering high-quality clinical data programming across multiple therapeutic areas, I support end-to-end programming for pharmacometrics, PK/PD, NONMEM, ADNCA, CDISC, and global regulatory submissions including FDA and PMDA and completely working on R Programming.Key Responsibilities: Pharmacometrics / NONMEM, ADNCA Programming, eSub activities Develop and QC NONMEM-ready datasets Oncology, Neuroscience, INI, and Immunology studies, Support population PK/PD and exposure–response analyses across multiple study designs (single-dose, multiple-dose, parallel, crossover), Work closely with clinical pharmacology and modelling teams to ensure high-quality pharmacometrics deliverables ADNCA & NCA Programming, Develop ADNCA datasets following NCA standards for PK analyse in Oncology and other therapeutic areas, support non-compartmental analysis workflows and generate summary outputs for PK evaluations, assist in generating PK concentration-time listings, descriptive stats, and PK/PD summary plotsRegulatory eSub (FDA & PMDA): Contribute to complete FDA eSubmission packages, including:SDTM & ADaM datasets, PK/PD eSub for FDA/PMDASDTM & ADaM DevelopmentProgram SDTM and ADaM datasets across Oncology, Neuroscience, Immunology, INI and other Tas. Work on complex ADaM derivations including PK/PD, time-to-event endpoints, dose modifications, ADNCA, ADPP, ADPC.Tables, Listings & Figures (TLF)Generate high-quality TLFs for CSR submissions, including:Safety and efficacy summariesOncology-specific outputs (RECIST metrics, tumor response, PFS/OS analyses)PK/PD figures: spaghetti plots, conc-time profiles, exposure-response plots.Compliance & Collaboration: Deliver programming support across multiple phases (Phase for diverse therapeutic areas using R programming and SAS programming.Technical ExpertiseSAS, R, NONMEMCDISC: SDTM, ADaM, Define.xml

Education

• North Maharashtra University

  Master of Science - MSc

  2017 — 2019

• North Maharashtra University

  Bachelor of Science in Statistics

  2014 — 2017