Ankit Patel
About Ankit Patel
Ankit Patel is a Senior SAS Programmer with extensive experience in statistical programming and clinical trials data management. He has worked for several prominent pharmaceutical companies and holds multiple degrees in pharmacy and engineering.
Work at Kite Pharma
Ankit Patel has been employed at Kite Pharma as a Senior SAS Programmer since 2018. In this role, he focuses on creating and validating SDTM and ADaM datasets, as well as TLFs. He transforms data from various formats, including Excel, CSV, and Oracle databases, into SAS datasets. His responsibilities also include creating CDISC SDTM V 3.1.2 and ADaM domains from legacy datasets, ensuring adherence to sponsor data standards.
Previous Experience in Statistical Programming
Prior to his current position, Ankit Patel worked at several organizations in statistical programming roles. He served as a Senior Statistical Programmer at Biogen from 2015 to 2018. Before that, he held the position of Sr. Statistical Programmer at Parexel from 2014 to 2015, and worked as Statistical Programmer II at Eisai US from 2013 to 2014. His career began at PharmaNet/i3 Strategic Resourcing, where he worked as a Statistical Programmer from 2012 to 2013.
Education and Expertise
Ankit Patel holds a Doctor of Pharmacy (PharmD) degree from Nirma University, where he studied Pharmaceutical Sciences from 2010 to 2011. He also earned a Bachelor's degree in Pharmacy from Poona College of Pharmacy, completing his studies from 2001 to 2005. Additionally, he obtained a Master's degree in Industrial Engineering from Long Island University in 2008 and an MBA in Healthcare from Dowling College, which he completed in 2014.
Clinical Trials and Data Management Skills
Ankit Patel possesses extensive experience in clinical trials safety data management. His expertise includes working with demographic data, adverse events, laboratory data, and efficacy data. He has created pooled datasets and TLGs for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for regulatory submissions. His skills also encompass cleaning and resolving data issues, merging data from various sources, and supporting regulatory submission activities.
Regulatory Submission Experience
Ankit Patel has supported regulatory submission activities by estimating deliverables for ad-hoc requests from internal clinical departments and regulatory agencies. He has mapped analysis datasets, tables, listings, and graphs for FDA and NDA electronic submissions. His good working knowledge of FDA regulations and GCP/ICH guidelines enhances his contributions to clinical programming processes.