G C Patel

Senior Biostatistician with a PhD in Statistics and over 16 years of experience supporting clinical research, pharmaceutical, and animal health organizations. Expertise in clinical trial design, statistical analysis, SAP development, TFL review, sample size estimation, and regulatory compliance (ICH-E9, GCP, FDA, EMA). Proven ability to collaborate with cross-functional teams and deliver high-quality, compliant statistical outputs across multiple therapeutic areas and study phases.

Assistant General Manager – Biostatistician - COD Research Pvt. Ltd. - Ahmedabad

(2024-01 - 2024-10)

• Provided end-to-end statistical support for clinical studies across the project lifecycle.
• Contributed to protocol and CRF review, sample size estimation, and randomization.
• Authored SAPs and developed mock TFL shells; performed detailed TFL reviews.
• Supported bid defenses, proposals, and budget development.
• Provided statistical input to DMC activities, interim analyses, and stopping rules.
• Reviewed CSRs and ensured compliance with internal quality systems and global regulations.

General Manager – Biostatistician - Zydus Lifesciences Ltd. - Ahmedabad

(2023-01 - 2023-10)

• Conducted statistical analyses using SAS and R for clinical research programs.
• Collaborated with cross-functional teams to meet regulatory and quality standards.
• Ensured timely delivery of statistical outputs aligned with project milestones.

Manager – Biostatistician - Elanco Innovation & Alliance Centre (IAC) - Bangalore

(2022-11 - 2023-01)

• Developed SAPs and provided statistical input for protocols and trial designs.
• Supported sample size estimation, randomization, and regulatory documentation.
• Worked closely with clinical, data management, and regulatory teams.

Deputy General Manager – Biostatistician - Veeda Clinical Research Ltd. - Ahmedabad

(2020-05 - 2022-11)

• Led statistical activities for clinical research projects.
• Reviewed and validated statistical programs and CDISC datasets.
• Provided mentoring and technical guidance to biostatistics teams.

Manager – Biostatistician - Cadila Healthcare Ltd. - Ahmedabad

(2016-12 - 2020-05)

• Delivered statistical analyses and reports for clinical research studies.
• Developed data visualizations and analytical summaries for stakeholders.

Lead Biostatistician - Cliantha Research Ltd. - Ahmedabad

(2006-04 - 2016-11)

• Managed biostatistics activities for clinical trials and bioequivalence studies.
• Coordinated with global clinical sites and ensured regulatory compliance.
• Oversaw multiple projects with timely and high-quality deliverables.

Officer Biostatistician - Sun Pharma Advanced Research Center - Vadodara

(2006-01 - 2006-04)

• Supported protocol development, sample size estimation, and statistical analysis.

Visiting Lecturer – Biostatistics & Data Science - School of Emerging Science & Technology - Ahmedabad

(2024-10 - 2025-09)

• Taught postgraduate courses in Biostatistics, Research Methodology, R, Python, and Machine Learning.
• Supervised academic projects using real-world datasets.

Visiting Lecturer – Biostatistics - Institute of Pharmacy, Nirma University - Ahmedabad

(2003-06 - 2005-12)

Team Member – Customer Service & Food Counter - Tim Hortons - Canada

(2025-10)

• Delivered customer service and maintained food safety and hygiene standards

PhD - Statistics - Gujarat University (2006 - 2012)