Stephen Matteson

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Sr. Director of Global Head of Programming Standards (Retired) @
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Naples, Florida, United States, United States
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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.

Stephen Matteson's Current Company Details
Pfizer

Pfizer

Sr. Director of Global Head of Programming Standards (Retired)
Stephen Matteson Work Experience Details
  • Pfizer
    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.
  • Pfizer
    Sr Director Programming Standards
    Pfizer Oct 2013 - Present
  • Pfizer
    Global Head Of Statistical Programming Standards
    Pfizer Oct 2013 - Present
  • Pfizer
    Sr. Director Of Programming Standards
    Pfizer Oct 2013 - Apr 2016
    In this role I lead and manage the implementation, delivery, and maintenance of programming standards across Pfizer Inc, including as appropriate Alliance Partners, regional partners, or other CROs in support of all Pfizer-sponsored clinical trials and for all Safety reporting and TA reporting. I am also responsible for leading and managing the implementation and delivery of safety and TA efficacy programming standards and ensure the quality and consistency of programming standards at partner companies and the data contained within the Pfizer repository towards the ultimate objective of data quality and consistency across programs and systems.
  • Quintiles Transnational
    Associate Director, Statistical Programming
    Quintiles Transnational Feb 2010 - Oct 2013
    Durham, North Carolina, Us
    My responsibilities include providing advanced clinical trial reporting technical expertise and experienced project/people management as a member of the GFR Bios Statistical Programming leadership team. •Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical analysis needs. •Provide advanced technical expertise to the Statistical Programming department. •Provide expert level SAS programming leadership and support. Develop analysis files, integrated databases, tables, listings, graphs for clinical trial and NDA submissions. •Currently manage 4 FTE statistical programmers along with 15 contract resources supporting a number of compounds and protocols from early development to commercialization.•Provide training, mentoring, and project consultancy to over 200 statistical programming resources located in North America, Europe, Asia, and South Africa. •Lead weekly technical and project delivery sessions with staff in Bangalore India.•Responsible for project tracking, resourcing, and delivery across multiple compounds and studies.o Customer Engagement Manager (Portfolio Management, Timeline Negotiations, Strategic Planning, Project Status Communications)-- Primary point of contact between client clinical project teams and Quintiles-- Managed clinical trial reporting delivery timelines-- Managed technical resources and delegate technical assignments-- Developed tools used to capture project status and maintain metrics on performance (Delivery) and quality (Rework)•Lead a continuous improvement initiative focused on ensuring quality and traceability within the Analysis and Reporting QC process. •In addition to being the project team lead, I have also been directly involved in the development and delivery of clinical reporting solutions to GFR critical projects.
  • Quintiles Transnational
    Statistical Programming Scientist
    Quintiles Transnational Feb 2010 - Jun 2011
    Durham, North Carolina, Us
    Core function and deliverables included:•Perform internal training, orientate and induct new staff, and perform role of mentor.•Directly contributed to the formation of the electronic submission (eSub)o Identifying and describing structure and keys to primary data sources contributing to the regulatory filingso Support the creation of the export (XPT) and define.pdf •Managed and contributed to clinical reporting which includes:o Blinded Data Reviews (BDR) – PDF Bundling of outputs, captured issues and tracked and managed defect resolutiono Data Monitoring Committee (DMC) – Quarterly frequency of safety and efficacy reporting across 10 ongoing clinical trialso Periodic Safety Updates (SAF09) – Internal safety review of ongoing studieso Final Clinical Study Reporting and regulatory submission of an experimental Renal Cell Cancer treatment to the FDA, EMA, Japan, Korean, and Russian regulatory agencies
  • Pfizer Pharmaceuticals
    Business Analyst / Sas Programmer
    Pfizer Pharmaceuticals Jan 2009 - Nov 2009
    New York, New York, Us
    Clinical Data Visualization utilizing SAS, Oracle, and Spotfire • Developed repeatable extraction and optimized translation routines of Oracle Clinical Safety Data using SAS that enhances the ability to surface data to clinical project teams through the use of Tibco Spotfire.Responsible for the re-engineering and delivery of the Safety and Risk Management (SRM) Periodic Safety Update and Annual Study Reporting (PSUR/ASR) off of the newly deployed Oracle/Siebel Clinical Trial Relationship Management (CTRM) system.
  • Pfizer Pharmaceuticals
    Informatics Director - - Clinical, Quantitative, And Innovative Medicine
    Pfizer Pharmaceuticals Sep 2005 - Dec 2008
    New York, New York, Us
    Strategic Program Director responsible for the IT strategy and portfolio delivery of solutions in support of the following business communities: Global Clinical Network, Global Statistic, Global Clinical Pharmacology, Molecular and Translational Medicine •Developed IT product & service strategies and associated project investment proposals that enable the successful advancement of business strategies within assigned area of responsibility•Co-chair of the business and informatics integrated progress team:-Establish and maintain IT Strategy that aligns with Business Strategy-Prioritize investments according to strategy-Portfolio responsibility for New and Sustain IT projects-Developed the Business and IT Governance Model to support the Strategic Initiative, Project Execution, and Operational Support•Manage and mentor the professional growth of internal Customer Engagement Managers, Project Managers, Technical Team Leads and Developers•Along with managing, I was also personally responsible for Customer Engagement and Project Management in the delivery of IT solutions to my customers•Responsible for ensuring product and service value is achieved via effective uptake and change management.•Responsible for a sustain and new development budget portfolio that exceeded $5M annually•Nominated by my team for the Pfizer Management Award•Continued to leverage SAS to manipulate and surface statistical and biomarker data stored in oracle tables. Migrated clinical biomarkers from J2EE/Oracle application to SharePoint providing over $125K in support savings.
  • Pfizer Pharmaceuticals
    Pfizer Inc. - Clinical Analysis & Reporting: Strategic Director, Technical Team Lead, Sas Software
    Pfizer Pharmaceuticals Aug 1992 - Sep 2005
    New York, New York, Us
    Clinical Data Analysis and Reporting System (CDARS) is a web based application that manages all of the regulatory clinical reporting requirements at Pfizer within a 21 CFR Part 11 compliant environment. It was first deployed in 1997 and is still the primary reporting environment at Pfizer today. I was responsible for managing the development and support of the user interface, all clinical reporting software development, along with the strategic planning and tactical implementation of the application from 1996 to 2005. Responsibilities included: •In-depth understanding of internal and industry clinical data standards (CDISC), clinical trial reporting processes and regulatory requirements•Provided direction and mentoring to the team and incorporated innovative approaches to the development of generic clinical reporting software•Reporting software is maintained at the system level and parameter and data driven techniques are used to accommodate the variation in clinical algorithms based on clinical study design•Parameter driven sub-setting and by variable processing•Ability to manually remap treatment labels for specific reporting purposes •Ability to generated standard study level safety and efficacy reports along with Integrated Summary of Safety (ISS) and Efficacy (ISE) is built into all of the reporting software•In addition to managing the development team, I was also the subject matter expert responsible for the development and support of all Adverse Events, Demographics, and Subject Final Summary reporting software
  • Rhode Island Department Of Health
    Statistical Programmer/Systems Analyst, Cancer Registry
    Rhode Island Department Of Health Oct 1986 - Aug 1992
    • Involved in the development of analytical tools used to analyze public health survey data• Lead developer of the Rhode Island Cancer Registry and Vital Statistics Death Index
  • Freelance Software Developer
    Consultant
    Freelance Software Developer Jan 1987 - Jan 1992
    Provided statistical programming and database development services to physicians and scientists conducting outcome and behavioral research on patients at Rhode Island and Merriam Hospital; Hospitalization data for the Neonatal Research Center in Providence Rhode Island; Development of an inventory and distribution system for a company called Healthcare Automation
  • Brown University
    Statistical Programmer
    Brown University May 1982 - Oct 1986
    Providence, Rhode Island, Us
    Provided statistical programming support using SAS, Spssx, and BMPS for principle investigators researching survey level data on oncology, neonatal, and gerontology studies

Stephen Matteson Skills

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

Stephen Matteson Education Details

  • University Of Massachusetts Amherst
    University Of Massachusetts Amherst
    Biology

Frequently Asked Questions about Stephen Matteson

What company does Stephen Matteson work for?

Stephen Matteson works for Pfizer

What is Stephen Matteson's role at the current company?

Stephen Matteson's current role is Sr. Director of Global Head of Programming Standards (Retired).

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What schools did Stephen Matteson attend?

Stephen Matteson attended University Of Massachusetts Amherst.

What skills is Stephen Matteson known for?

Stephen Matteson has skills like 21 Cfr Part 11, Pharmaceutical Industry, Clinical Trials, Clinical Development, Sas, Oncology, Clinical Research, Cro, Fda, Gcp, Biotechnology.

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