Rikkin Parekh
Principal Scientist, Statistical Programming @Merck
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WORK HISTORY
Principal Scientist, Statistical Programming @Merck
Rahway, NJ, US
Oversee multiple oncology projects, ensuring timely progression through all phases of development while maintaining alignment with strategic objectives and regulatory requirements.• Lead the creation and through review of electronic submission (eSubmission) packages, ensuring that all components including clinical study reports, regulatory documents, and supporting datasets are accurate, consistent and compliant with health authority guidelines.• Manage and coordinate the execution of statistical analysis and reporting deliverables, generating complex analytical datasets, tables, listings and figures for clinical studies, regulatory submissions, and post-market analysis.• Collaborate with cross-functional teams to facilitate the aggregation and integration of data for eSubmission packages, leveraging expertise in oncology therapeutic areas to enhance the quality and integrity of submissions.• Actively engage in the development and implementation of innovative strategies aimed at improving operational efficiency and enhancing project outcomes within the organization.• Serve as a primary statistical programming expert and resource throughout the product development lifecycle, ensuring adherence to programming standards and regulatory guidelines while mentoring team members in best practices.
EDUCATION
Rutgers University
Master of Science - MS, Business Analytics
Institute of Pharmacy, Nirma University
Bachelor of Pharmacy (B.Pharm.)
SKILLS
ABOUT RIKKIN PAREKH
Portfolio App - https://csninjajr.pythonanywhere.com/• Certified SAS Programmer with 13+years of clinical experience as a programmer/analyst in SAS programming, Data Analysis and Reporting for pharmaceutical and Healthcare Industries.• Led the programming efforts in the submission process for Trodelvy mUC (IMMU-132-06)[TRODELVY® (sacituzumab govitecan-hziy)]• Served as the lead programmer in support of NDAs for JAK2(ARD12181)[ INREBIC® (Fedratinib)]• Exceptional ability in problem solving, data analysis, complex reports generations.Demonstrated exceptional resource management skills to efficiently support multiple deliverables with overlapping timelines.• Successfully increased portability of existing SAS programs and created new programs using SAS macro variables to improve efficiency and consistency of the reports with macros.• Extensive experience working on clinical trials projects across Phase I, II, and collaborating closely with Biostatisticians, Clin Dev, Clin Ops, Clinical Programmers, Data Managers, and Statistical Programmers.• Organized and dependable candidate successful at managing multiple priorities with a positive attitude.• Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills.• Ability to handle multiple projects simultaneously with a high degree of accuracy.
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