Stephen Matteson

About Stephen Matteson

Pfizer Departure LetterTuesday, February 7, 20232:56 PMStatistical Data Sciences and Analytics (formerly SPA)- Global Standards CDISC AccomplishmentsIn the fall of 2017, we embarked on a mission to expand our programming standards organization to Chennai, India. By the spring of 2018, we welcomed Jeba Kumar as the lead of our India standards team. Over the following years, Yogesh, Abdul, Jeba, and I collaborated to define our vision for standards at Pfizer. This vision focused on developing an end-to-end process to deliver 100% of all CDISC SDTM, ADaM, and Results across our entire enterprise. This vision remains steadfast today. In 2022, we achieved 85% compliance in generating all CDISC safety, efficacy, and PRO/QOL endpoints using standard reporting software for all primary portfolio assets. While we have not yet reached 100% compliance, I am confident that this global team, under its current leadership, along with our extended leadership and development team, will make this a reality.CDISC SDTM Standards DevelopmentOur team has successfully developed and deployed into production 294 Safety & Efficacy Standard SDTM Domains, supporting over 300 concurrent clinical trials managed within CD/InForm, Oracle Clinical, and PIMS. This effort will also extend to our next-generation RedCap CDMS/EDC system.CDISC ADaM/TLF Standard DevelopmentWe have also successfully developed and deployed into production 255 ADaM datasets and 307 Tables & Figures. While standard development is still primarily executed using SAS, under the leadership of Neetu Sangari, we have expanded our capabilities in R and Python to build frameworks for delivering CDISC SDTM, ADaM, Tables, and Figures.Pfizer India Standards Development TeamOne of the most rewarding achievements in my 30+ years at Pfizer has been the creation of our team in Chennai, India.Standard automated reporting software has its roots in the early 1990s at Pfizer. This effort spans the entire Pfizer enterprise and has been critical in delivering vaccines, lifesaving therapies, and oncology drug treatments for over 20 years. I am eternally grateful to my leadership team, including Yogesh Gupta, Abdul Khayat, and Jeba Kumar, for driving our strategy, delivery, and providing mentorship and support to our teams in North America and India.Most of all, I am grateful for the wonderful, caring, talented, and kind people I have met throughout this journey.I will always be thankful to Pfizer for giving me this opportunity.

Experience

1. Sr Director of Clinical Data, Analysis & Reporting Standards

   Pfizer

   Apr 2016 — Present

   One Thing - Focus:Pfizer End-to-End enterprise level implementation and automation of CDISC Standards is unprecedented in the industryDeveloping enterprise standard Clinical Data Analysis & Reporting solutions needed to support the delivery of new, effective and affordable drugs to patients is a complex challenge requiring cross functional collaboration within the Clinical Data & Operations and Global Biometrics and Data Management organizations. This effort requires discipline early on in the authoring of our protocols and defining of requirements need to develop data collection, analysis and reporting (A&R) standards. Rigorous software engineering principles are also applied in the design, development, test, and release of our standards for production use on our portfolio. Enterprise level governance of our standards and a robust change control process is critical to our success.The availability of standard data collection and A&R reporting software are essential if we are going to be successful in meeting our 2018 goals of being 95% compliant to data standards and 80% compliant to A&R standards.There are also 100’s of new efficacy endpoints that still need to be developed and to complete this task requires active participation by key stakeholders within the CD & O and GBDM organization in partnership with the Data and Analysis & Reporting Standards teams.Current Status:• The Data and Analysis & Reporting Standards team have successfully implemented end-to-end standards for all of core safety (14 domains) and over 80 efficacy endpoints spanning 8 Therapeutic Areas.• The team also released our first phase of CDISC standard code for Oncology and Vaccines on June 9th.• The team is also actively involved in the development of 68 efficacy endpoints.

Education

• University of Massachusetts Amherst

  Bachelor of Science, Biology

  1978 — 1982

Skills

• Pharmaceutical Industry
• Fda
• CRO
• Biotechnology
• Clinical Research
• Clinical Development
• 21 Cfr Part 11
• Sas
• Clinical Trials
• Gcp
• Oncology