Achyut Shashishekhar Pratap
Senior Statistical Programmer at Johnson and Johnson| Statistical R & SAS Programmer | SQL | Base SAS Certified | BI & Analytics | Data Engineer | Data Analytics
- Role
- Experienced 1 Statistical Programmer at Johnson & Johnson
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Achyut Shashishekhar Pratap
I’m a Senior Statistical Programmer with 7+ years of experience, specializing in delivering data solutions that drive the success of clinical trials. My expertise spans SAS and R, with a strong track record of developing, validating, and analyzing ADaM, SDTM, and generating TFLs (tables, figures, listings), and supporting regulatory submissions and clinical study reports. Key Highlights:> Leadership & Mentorship: Led programming teams, providing guidance to junior staff and ensuring high standards of quality in all programming deliverables.> Clinical Data Expertise: Experienced in analyzing efficacy and safety endpoints such as PFS, ORR, Compliance, Symptom improvement and other endpoints, ensuring data integrity and compliance.> Regulatory Compliance: Thorough knowledge of CDISC, FDA, ICH E6 guidelines, ensuring that all programming deliverables meet regulatory requirements and industry standards.> R & SAS Programming: Proficient in both SAS and R for data transformations, statistical modeling, and automating programming workflows to improve efficiency.> ADRG & P21 Validation: Expertise in using the ADaM Dataset Reviewer\'s Guide (ADRG) to ensure datasets are in compliance with regulatory standards. Experienced in P21 validation to guarantee the consistency and accuracy of datasets prior to regulatory submission.> Agile Environment Experience: Proven success working in an Agile environment, collaborating closely with cross-functional teams and adapting quickly to evolving project requirements to ensure timely delivery of programming outputs.> Process Improvement: Focused on streamlining workflows and boosting team efficiency through the development of SAS macros and R scripts.> Cross-Functional Collaboration: Worked alongside biostatisticians, clinical teams, and regulatory affairs to ensure programming deliverables align with study goals and regulatory timelines.I’m passionate about optimizing clinical programming processes, driving data-driven decisions, and contributing to the success of clinical trials. In Senior roles, I thrive in leadership positions where I can guide teams, innovate processes, and make an impact on clinical research outcomes.Let’s connect and discuss how I can contribute to your team’s data initiatives and drive clinical research forward.
Experience
Experienced 1 Statistical Programmer
Nov 2025 — Present · Mumbai, IN
Education
St. Clair College
Postgraduate Degree, Data Analytics for Business
SHARAD PAWAR INTERNATIONAL SCHOOL & JR. COLLEGE
Secondary School, 10th
2004 — 2011
Terna Engineering College
Bachelor of Engineering (B.E.), Computer Engineering
2013 — 2017
GTP Jr. College
High Secondary School, 12th, Science
2011 — 2013
S.A.M. English Medium School
School, 3rd
2001 — 2004
Skills
- Project Management
- Public Speaking
- Research
- Management
- Big Data Analytics
- Leadership
- Ios Development
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