Sandeep G.

About Sandeep G.

A highly skilled Statistical SAS Programmer with over 5+ years of experience specializing in regulatory submissions (CSR, NDA, including ISS and ISE). Well-versed in FDA and PMDA regulations, 21 CFR Part 11 guidelines, GCP guidelines, and major aspects of clinical development. Strong communication and interpersonal skills, working closely with statisticians and scientists to provide programming support for data analysis, report generation, tables, and graphs aligned with company standards.> 5+ years of industry experience, including leadership in FDA, PMDA, and EMA submissions and inspections.> Expertise in project management across multiple therapeutic areas, including Oncology, Rare Diseases, Neurology, Infectious Diseases, Hematology, Dermatology, Ophthalmology, Respiratory, Musculoskeletal, Urology, Toxicology, Rheumatology, Reproductive Health, Neonatology, Immunology, and Endocrinology.> Extensive experience in global team management, including project oversight, recruitment, onboarding, mentoring, and training.> Proficient in writing and reviewing SOPs, training materials, and validation documentation.> SAS Certified with strong expertise in SAS Base, SAS Macros, SAS/SQL, and CDISC Standards.> Proven track record in establishing and leading global process improvement initiatives, such as the Macro and Application Development Committee.

Experience

1. Statistical Programmer

   Cytel

   Oct 2025 — Present · Hyderabad, IN

Education

• Osmania University

  Master of Science - MS, applied statistics

  2017 — 2019