Freshers Experienced Professionals Enterprises Academia

Elevate Your
Team's
Expertise

Empower Your Team with Advanced Skills

Lead the industry. Elevate your team with cutting edge biostatistics & statistical programming expertise

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Interactive Discovery: Find Your Training Path

Explore customized training options based on your enterprise’s needs. Choose from focused expertise or a complete end-to-end solution.

Data Analysis Enhancement

For teams focused on clinical data analysis.

Enhance Data Analysis Skills 

Standardize clinical trial data using CDISC SDTM data standards for regulatory submission.

Streamline data transformation for statistical analysis using CDISC ADaM data standards

Perform statistical analysis and generate Tables, Listings, and Figures for clinical study report preparation.

Equip your team with End-to-End clinical trial data standardisation, statistical analysis and reporting.

Clinical Trial Innovation

For teams advancing clinical trial designs.

Lead Clinical Innovation 

Develop innovative implementation strategy for preparing regulatory complaint case report tabulations a cording to CDISC SDTM and ADaM data standards.

Develop automated workflow for data transformation, analysis and reporting of clinical trials

Develop and validate data extraction and analytics algorithms for product innovations.

Keep your team abreast with new and changing technologies like AI/ML tools and novel study designs and statistical methodologies

Regulatory Compliance and Reporting

For teams ensuring regulatory compliance.

Boost Compliance Proficiency 

Organize regulatory submission data packages in compliance with ICH guidelines.

Ensure all reports meet regulatory standards and audits.

Manage clinical trial data workflow from collection to final reporting in accordance to regulatory standards

Remove " Research and Development" section

Data Analysis Enhancement

For teams focused on clinical data analysis.

  SStandardize clinical trial data using CDISC SDTM data standards for regulatory submission.

  Streamline data transformation for statistical analysis using CDISC ADaM data standards

  Perform statistical analysis and generate Tables, Listings, and Figures for clinical study report preparation.

  Equip your team with End-to-End clinical trial data standardisation, statistical analysis and reporting.

Clinical Trial Innovation

Teams primarily engaged in data analysis, looking to deepen their expertise in statistical programming for clinical trials.

  Develop innovative implementation strategy for preparing regulatory complaint case report tabulations a cording to CDISC SDTM and ADaM data standards.

  Develop automated workflow for data transformation, analysis and reporting of clinical trials

  Develop and validate data extraction and analytics algorithms for product innovations

  Keep your team abreast with new and changing technologies like AI/ML tools and novel study designs and statistical methodologies

Regulatory Compliance and Reporting

Teams primarily engaged in data analysis, looking to deepen their expertise in statistical programming for clinical trials.

  Organize regulatory submission data packages in compliance with ICH guidelines.

  Ensure all reports meet regulatory standards and audits.

  Manage clinical trial data workflow from collection to final reporting in accordance to regulatory standards

Why This Program? Highlighting Unique Benefits

We provide various special
features for all of you

Industry pioneers lead the way

20+ Global Experts
Real-World Projects Integration

Hands-on projects driving industry change

Access Exclusive Data Sets
Publish and Innovate

Connect with the best

100+ Enterprises Engaged
Worldwide Academic Partnerships

Meet Your Mentors

Our mentors are industry veterans passionate about sharing their knowledge and experience.
They're here to guide you every step of the way, from your first lesson to your first job offer.

Interactive Curriculum Explorer

Tailor your team’s learning journey by choosing a specialized course in a key area or opt for the comprehensive End-to-End program. Whether your team needs to master one skill or gain a complete understanding of clinical data processes, STAT analytics offers flexible solutions to meet your needs.

Option 1: Specialized Training in Key Areas

Your team can focus on one of the following critical areas based on your enterprise’s immediate needs:

SDTM Expertise:

Master the Study Data Tabulation Model (SDTM) to standardize clinical trial data for regulatory submissions, ensuring compliance with global standards.

  • Learn the fundamentals of SDTM structure and domains.
  • Develop efficient data mapping and conversion techniques.
  • Understand best practices for handling trial data submissions.
  • Ensure compliance with FDA, EMA, and other regulatory guidelines.
  • Use tools like SAS to automate report generation.

ADaM Proficiency:

Focus on the Analysis Data Model (ADaM) to streamline data analysis and reporting, ensuring consistency and accuracy in clinical trials.

  • Learn ADaM principles and standards.
  • Develop data sets optimized for statistical analysis.
  • Explore techniques to simplify data traceability for regulatory review.
  • Create analysis-ready datasets to support submission compliance.
  • Use tools like SAS to automate report generation.

TLF Mastery:

Specialize in Tables, Listings, and Figures (TLF) to generate compliant and comprehensive reports for clinical trials, ensuring clarity and compliance in data presentation.

  • Understand the role of TLF in clinical reporting.
  • Design high-quality tables, listings, and figures that meet regulatory expectations.
  • Use tools like SAS to automate report generation.
  • Ensure data integrity and clarity in trial submissions.

Biostatistics

Build a strong foundation in biostatistics to enhance clinical trial analysis and reporting, contributing to robust, data-driven decisions.

  • Understand the fundamentals of biostatistics for clinical research.
  • Conduct thorough protocol reviews for statistical integrity.
  • Develop comprehensive Statistical Analysis Plans (SAP).
  • Perform efficacy analyses to evaluate treatment outcomes.
  • Create data-driven Clinical Study Reports (CSR) for regulatory submission.

Leadership

Empower your team with leadership skills specific to clinical research and data management, fostering a collaborative and efficient work environment.

  • Cultivate strategic decision-making in clinical project management.
  • Develop communication skills to effectively lead cross-functional teams.
  • Foster a culture of innovation and adaptability within clinical trials.
  • Enhance problem-solving skills for high-stakes situations in research.
  • Mentor and guide team members in best practices and ethical standards.

Option 2: End-to-End Training Program

For enterprises seeking comprehensive training, our End-to-End Program equips your team with in-depth expertise across SDTM, ADaM, TLF, Biostatistics, and Leadership. This holistic program ensures proficiency in every stage of clinical trial data management and reporting, from initial data collection to regulatory submission.

Equip Your Team with Full-Spectrum Expertise:

  • Master SDTM: Standardize clinical trial data for compliance with global regulatory requirements.
  • Optimize ADaM Analysis: Build datasets optimized for statistical analysis and regulatory traceability.
  • Ensure Reporting Clarity with TLF: Design high-quality tables, listings, and figures for clear data presentation
  • Strengthen Biostatistics Foundations: Conduct protocol reviews, efficacy analyses, and prepare study reports.
  • Develop Leadership Skills: Enhance strategic decision-making and effective team management in clinical research.

Design a Program That Fits Your Enterprise

Select and combine modules to see how our flexible training adapts to your needs

Plans Available

Custom Selection


Selected Plans

Contact us Today

Your journey to academic and research leadership starts here. Apply now to take the first step towards redefining clinical trials research.

Have Questions? We’ve
Got Answers

Explore common inquiries to ensure you’re fully informed about
empowering your team.

Yes, our training is fully customizable based on your enterprise’s specific requirements, from SDTM, ADaM, TLF, to End-to-End programs.

The duration varies depending on the depth of training, but we offer flexible scheduling to fit your team’s availability.

We offer both virtual and onsite training options based on your preferences and operational needs.

We offer post-training support, including follow-up sessions, access to resources, and continuous learning materials for your team.

Our program enhances your team’s proficiency in clinical data management, leading to improved accuracy, compliance, and faster project execution.

Yes, you can choose to train employees in one specific area or opt for comprehensive End-to-End training covering all aspects.

Dr Michael Willett Pharm.D

President & CEO, Ready Clinical, LLC, USA

Dr. Willett has more than 30 years of clinical research experience and provides consulting services for clinical protocol design, clinical data interpretation, PK/PD, efficacy and safety analyses, regulatory affairs and medical writing. He has extensive clinical trials experience in Phase I‑IV clinical trials in a wide range of therapeutic areas.

Dr. Willett started his career as a clinical pharmacist in a progressive hospital providing critical care, cardiology, infectious disease, nutritional team support and therapeutic drug monitoring. He transitioned into the biopharmaceutical industry and was involved in all phases of clinical research and multiple product launches at Marion Laboratories and Bristol-Myers Squibb.

Dr. Willett received his Bachelor and Doctor of Pharmacy degrees with Honors from University of Illinois and completed an adult internal medicine residency at Truman Medical Center in Kansas City.

Shaileshkumar Patel, B.Tech.

Data Architect and Data Migration specialist

Shaileshkumar Patel is a seasoned Data Architect and Data Migration specialist with over 19 years of extensive experience in Oracle Database development and administration. He has specialized expertise in the pharmaceutical and IT sectors, notably within clinical-related applications in Good Clinical Practice (GCP) regulated environments and ITIL Configuration Management Database Systems (CMDB). His technical proficiency spans multiple versions of Oracle databases (8i to 12c), and he is adept in SQL, PL/SQL, database performance tuning, backup, recovery, and database migration.

Mr. Patel’s professional experience includes significant roles at Novo Nordisk IT (NNIT), where he served as a Senior Data Architect and Data Analytics Engineer for clients like Genmab. His responsibilities encompassed designing data models, managing research data analytics platforms using AWS tools, and overseeing validation and quality assurance processes.

Shaileshkumar is known for his excellent teamwork and communication skills, which he leverages to provide clear, practical guidance to aspiring data science professionals.

Dr. Russell Reeve, PhD

Vice President, Biostatistics and Statistical Programming Syneos Health, USA

Dr. Russell Reeve is a seasoned expert in Biostatistics and statistical programming with over 30 years of experience in the pharmaceutical industry and academia. Currently, he serves as the Vice President of Biostatistics and Statistical Programming at Syneos Health, supporting full-service studies globally. He drives innovation and use of AI/ML within Biostatistics function. Prior to this role, Dr. Reeve served as Vice President of Biostatistics and Decision Sciences at IQVIA, where he led a global team across multiple regions, including North America, Europe, and Asia. Dr. Reeve has a proven track record in transforming business units, as evidenced by his successful turnaround of a previously loss-making P&L into a profitable center, achieving an 18% CAGR in revenue for the Decision Sciences group.

He holds a Ph.D. in Statistics from Virginia Polytechnic Institute and State University and has extensive experience in clinical trial design, machine learning applications, and regulatory submissions. Dr. Reeve has led multiple software development projects, introducing innovative solutions such as SaaS products and machine learning tools to enhance clinical trial efficiency.

Anil Kumar M.Sc. M.Tech.

Program Director

Anil Kumar is a distinguished authority in Biostatistics and Statistical programming, boasting over three decades of unparalleled expertise in drug development across the globe. With an M.Sc degree in Statistics from MG University, Kottayam and M.Tech degrees in Quality, Reliability and Operations Research from India Statistical Institute, Kolkata, Anil has solidified his reputation as a thought leader in the field of Biostatistics and Statistical Programming.

Having navigated the corridors of global Contract Research Organizations (CROs) and pharmaceutical giants, both in India and abroad, Anil brings a unique perspective shaped by diverse cultural landscapes and industry nuances. His extensive tenure in these renowned establishments has not only enriched his professional acumen but also solidified his commitment to excellence in clinical research.

Beyond his illustrious career trajectory, Anil has served as a beacon of knowledge, spearheading numerous training programs in Biostatistics and Statistical Programming. Participants can expect to be guided by his wealth of experience, gaining invaluable insights, practical skills, and industry best practices honed through decades of global engagement.

Embark on a transformative journey with Anil Kumar in our training program, where expertise meets diversity, and knowledge transcends borders to fuel groundbreaking advancements in clinical research worldwide.