Thomas A. Kalfas

Palatine, IL ***** 847-***-****

ad2m3g@r.postjobfree.com

Life Sciences and Healthcare Professional

Software Development Operations Management Biostat Programming Team Building & Leadership

Senior Life Sciences professional with more than 20 years of experience in pharmaceutical, biotechnology and healthcare industries providing SAS support and technical management. Proven track record of developing and executing strategic plans sustaining operational effectiveness and driving financial improvement. Intuitive leader with acute business acumen and expertise in building and leading global high performance teams to drive transformational change, innovation, and value creation.

Software/Product Development

Team Building & Leadership

Process & Quality Improvements

Assessments & Roadmaps

Operations Management

Client Relationships

Dataset & TFL Delivery

Solution Design & Delivery

Biostatistical Programming

Infrastructure Growth

Organizational Initiatives

Technical Troubleshooting

Professional Experience

GCE SOLUTIONS (GENINVO Since 2017) 01/2016 – 04/2023

Global Head, Innovative Solutions & Senior Innovation Officer Bloomington, IL

Built a cross-functional, global team to incubate and develop innovative software solutions and services to support internal and external operational teams in the Life Sciences industry.

Identified, recruited, onboarded and developed team members to support innovations development and services.

Leveraged my experience in the industry and in building teams and new capabilities, but also my significant SAS programming, SQL, UNIX shell scripting, and general design/development and problem-solving skills to establish an industry leading software and services provider.

Established SOPs, qualified processes, and tools to support development, testing, validation, code versioning, and release management activities in compliance with industry regulations and best practices.

Assisted teams with execution of test scripts and documentation for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.

Introduced test script automation to achieve 80% efficiency in execution and enabling regression testing for all releases, patches and hotfixes.

Provided webinars and presented at industry conferences on requirements/compliance for data sharing/transparency.

Leading AI/ML/Data-Science teams to hasten industry adoption of related technologies to streamline and enhance quality of historically very repetitive, time-consuming processes.

Supervising and mentoring team members, coordinating workflow and prioritizing and delegating tasks to ensure completion according to established timelines.

Cultivating excellent relationships with clients, maintaining ongoing interactions and facilitating solutions to address concerns.

Driving business to improve profitability, assisting in defining departmental visions and developing process improvement strategies.

D-WISE TECHNOLOGIES 04/2013 – 12/2016

Senior Director, Life Sciences Practice; Principal Solutions Consultant Morrisville, NC

Proactively provided operational support for key projects, including updating statistical computing environment and managing data migrations.

Leveraged my experience in the industry, my significant SAS programming, SQL, UNIX shell scripting, and general design/development and problem-solving skills to assist with design, development and testing of custom application development projects.

Supervised and mentored all Life Science team members, coordinating workflow and prioritizing and delegating tasks to ensure task completion according to established timelines.

Cultivated excellent relationships with clients, maintaining ongoing interactions and facilitating solutions to address concerns.

Drove business to improve profitability, assisting in defining departmental visions and developing process improvement strategies.

PREMIER RESEARCH GROUP 06/2006 – 03/2013

Global Director, Biometrics (Technical Operations) Chicago, IL

Managed operations for CRF Development, Database Development, and Programming groups.

Led strategic planning for key initiatives, including CDMS and SOP integration, EDC and CDISC strategies and implementations.

Developed IT best practices based on innovative technologies for complex and critical projects, such as regulatory submissions and dataset production.

Provided leadership to all members of the skill center for initiatives that improve quality, efficiency and resourcing. Such initiatives include CDMS and SOP integration, EDC and CDISC strategies and implementations.

Provided support for all of Premier’s data management, CRF development, clinical database builds, biostatistical programming and data migration projects.

Directed and provided hands-on programming support/development for complex/critical projects, e.g., regulatory submissions, rescue studies, data/specification-driven production of datasets and listing, CRF annotations generator, lab data conversion processes/programs, etc.

Provided, led, and mentored programming support for database management and programming deliverables (SQL, SAS programming, Shell and Perl scripting).

Supported all necessary Extract-Transform-Load (ETL) activities in a controlled/documented manner.

Responsible for development, maintenance and execution of test scripts to ensure availability of critical systems and applications supporting the Technical Operations activities. testing., my experience with SOPs, process validation, and quality improvements indicates a familiarity with test management software. My familiarity with both Waterfall and Agile methodologies also speaks to my robust understanding of Software Development Life Cycle (SDLC), testing methodologies, tools, and processes.

Controlled resource allocation, planning, scheduling, and coordinating timelines with internal and external stakeholders and vendors.

Conducted needs assessments to identify continuous process improvements to streamline business processes and improve quality standards.

AMGEN, INC. 03/2005 – 06/2006

Manager, Biostatistical Programming Thousand Oaks, CA

Responsible for recruitment, management and leadership of staff within Programming Therapeutic Area (TA) group.

Maintained and improved global collaboration within the Programming function.

Ensured all programming outputs pertaining to individual clinical studies, ISS/ISE, and non-registrational activities meet required standards and are validated and correct.

Ensured best programming practice through leadership of programming process improvement initiatives.

Responsible for generating data-marts to house safety and efficacy data for Inflammation studies.

Responsible for evaluating existing infrastructure and augmenting as appropriate to better handle growing department and in-sourcing of future studies. This included leadership of and participation on committees focused on Unix, SAS, SOPs, and industry standards, e.g., CDISC, ICH.

UNITED AIRLINES 06/2004 – 03/2005 (9 months)

Systems Analyst/Developer, IT (Consultant) Chicago, IL

Technical lead and mentor for an implementation team responsible for the implementation of a Sales Force Effectiveness system. This 3-tiered system had been developed by a third party and had been run on a monthly basis to generate data and reports for United’s Sales Group to use in monitoring corporate and retail contracts pipeline data. My team was responsible for implementing and executing this system on United’s production servers.

My responsibilities on this project were primarily to analyze and gain familiarity with the existing system on its native platform and to resolve SAS implementation issues (SAS environment, base SAS, macro, SAS/Connect, SAS/Share, and SAS/AF/SCL issues). I had also provided direction as to standards for new Unix environments and the SAS Version 9 installations on these servers.

SPIEGEL CORPORATION 01/2004 – 06/2004 (6 months)

Systems Analyst/Developer, IT (Consultant) Chicago, IL

Technical lead and mentor for an implementation team responsible for the implementation of a Marketing and Merchandising Application (MAMA). The MAMA application was originally developed by an affiliate, Newport News, Inc. The application was ported over to the LAN(NT), Unix (Sun), and Mainframe (OS/390) servers at Spiegel.

My responsibilities on this project were to analyze and gain familiarity with the existing system on its native platform and to resolve SAS implementation issues (SAS environment, base SAS, macro, SAS/Connect, SAS/Share, and SAS/AF/SCL issues).

I spent a significant portion of my time mentoring entry-level SAS programmers. Among the issues identified were version 6 to version 8 migration, cross-platform communications and transfer issues (LAN to Unix, LAN to Mainframe, Mainframe to Unix), and system components that had become dysfunctional during migration.

Designed, developed, tested and implemented scripts, SAS programs, macros and JCL’s to facilitate job logging and error reporting, and various other utilities.

Debugged and re-implemented SAS/Share and SAS/Connect products on multiple platforms.

Enhanced cross-platform communications using SAS/Connect and RLS libraries to facilitate sharing/leveraging of SCL methods stored on a single platform.

CAREMARK, INC. 10/2002 – 01/2004 (16 months)

Systems Analyst/Developer, IT (Consultant) Chicago, IL

Project lead and technical lead for MCDI project (Medical Claims Data Integration). My responsibilities included project management and navigation of SDLC activities. These activities involved the analysis of the previous IHDB load system, the gathering of user requirements for the new MCDI system, the generation of functional requirements, the definition of detailed system/design specifications, development, testing, system implementation, documentation, and the provision of technical guidance/support.

Additional project management duties had included the establishment of project charts/timelines (MS Project), the guidance and monitoring of project/development activities, the facilitation of weekly team meetings, and interaction with other IT groups as necessary for completion of the project.

Supported the SAS and Unix needs of IS Analytics staff and clients by providing utility scripts and programs (e.g., worked to establish Unix print queues, implemented print scripts). Offered input for SOPs and system efficiencies, e.g., Programming Standards, and establishing a standard SAS environment and definition of standard macro libraries.

SCHERING-PLOUGH, INC. 07/2002 – 10/2002 (3 months)

Clinical Trial Programmer (Consultant) East Rutherford, NJ

Technical lead and mentor for an implementation team responsible for the implementation of a Sales Force Effectiveness system. This 3-tiered system had been developed by a third party and had been run on a monthly basis to generate data and reports for United’s Sales Group to use in monitoring corporate and retail contracts pipeline data. My team was responsible for implementing and executing this system on United’s production servers.

My responsibilities on this project were primarily to analyze and gain familiarity with the existing system on its native platform and to resolve SAS implementation issues (SAS environment, base SAS, macro, SAS/Connect, SAS/Share, and SAS/AF/SCL issues). I had also provided direction as to standards for new Unix environments and the SAS Version 9 installations on these servers.

Supported the needs of staff and clients for statistical programming and generation of clinical trial study reports for drugs in phases 1 through 3. Generated patient profiles, ISS and ISE reports. Worked extensively with base SAS, macros and statistical procedures. Performed system maintenance duties using primarily SAS and UNIX shell scripts.

FUJISAWA HEALTHCARE, INC. 04/2001 – 07/2002 (15 months)

Clinical Trial Programmer (Consultant) Chicago, IL

Supported the needs of staff and clients for statistical programming and generation of clinical trial study reports for a cardiovascular drug in phases 1 through 3. Produced tables, listings and graphs for clinical trials, ISS and ISE reports in accordance with statistical analysis plans.

Developed and implemented standardized data specifications for providers of electronic data, e.g., laboratory, ECG, holter data. Set of macros required sophisticated data processing techniques and interaction with Excel spreadsheets via DDE links.

Developed, tested and implemented programs to generate data specifications for data providers, and other programs to load electronic data using specifications stored in metadatasets.

Worked closely with Pharmacokinetic group to automated loading of PK data. This process included programs to load and check the incoming data, and to add analysis variables. The programs loaded data from various Microsoft formats (i.e., Excel and Access) into SAS datasets for QA and cleansing. The analysis datasets were also stored as Excel spreadsheets for use by the PK analysts.

SEARLE/PHARMACIA 02/2000 – 06/2001 (16 months)

Systems Analyst/Developer (Consultant) Skokie, IL

Developed, tested, implemented and maintained a suite of SAS programs, macros, shell/awk scripts and Perl scripts to generate interface files for loading Prescriber, Pharmacy, Clinic and Hospital data into a Sales Force Automation system.

Responsibilities also included the investigation and cleaning of data using SAS, Oracle (SQL), and shell scripts.

ABBOTT LABORATORIES 02/1996 – 06/2000 (52 months)

Systems Analyst/Developer & Clinical Trial Programmer (Consultant) North Chicago, IL

Supported the needs of staff and clients for statistical programming and generation of clinical trial study reports in phases 1 through 3. Also performed system maintenance duties using primarily SAS, UNIX scripts, and VAX DCL command/batch files.

Developed, tested, implemented and maintained a user interface (using Shell, Awk and Perl scripts) to initiate a set of SAS macros to reconcile adverse event databases on different platforms (VM: Nomad, and Unix: Oracle and SAS). The scripts were developed using Korn shell, Awk, and Perl scripts. Users were able to schedule jobs to execute on a particular date and time or at specific intervals (e.g., every 30 days). Other administrative options were also available to the users to allow viewing, modifying, and deletion of previously scheduled jobs.

Participated on a project team commissioned to automate the generation of electronic NDA submissions. As part of that team, I chronicled the processes involved, researched reasonable options and then designed, developed, tested, implemented and maintained various SAS programs, macros, shell and Perl scripts to assist in automating the process.

Enhanced and maintained an existing GUI application (SAS/AF, SCL, and Frame) to initiate a set of SCL and Macro programs to generate various reports and spreadsheets (via ODBC) for drug packaging data. Developed, tested, implemented and maintained a user interface (Korn shell and Awk scripting) to initiate a clinical data review tool (SAS: Explorer). Assisted in preparing training and reference materials.

Facilitated a cross-departmental product review, implemented and administrated a company-wide installation of the clinical data review package, SAS/PH-Clinical. As part of this implementation, I developed data interface programs to automatically load study definitions prior to the availability of an official batch load facility.

Developed, tested, implemented and maintained a GUI system used for entry of medication classes using SAS/AF, Frame and SCL.

Developed, tested, implemented and maintained a set of SCL programs to generate functional specifications on any standardly documented program(s) for validation documents. This generator had also been used for checking program documentation for adherence to department standards.

Maintained data dictionary and medication classification systems written entirely in SAS/Frame and SCL. Responsible for user-support and system maintenance.

G.D. SEARLE & COMPANY 01/1994 – 02/1996

Co-Leader, Oncology Franchise Skokie, IL

Supervised and managed production of programming, statistics, database, and data management team members; resolved issues having potential to delay production of final study reports. Performed these activities while also serving as the team’s lead programmer (see “Senior Statistical Programmer” below).

Incorporated timesaving procedures to reduce clinical trial data processing cycle times.

Led weekly team meetings and managed project activities.

Collaborated with reengineering team to facilitate optimal functioning of STAR Team and Technical Expertise Groups by implementing new processes, information systems, and organization practices.

G.D. SEARLE & COMPANY 01/1990 – 01/1994

Senior Statistical Programmer Skokie, IL

Supported the needs of staff and clients for statistical programming and generation of clinical trial study reports in phases 1 through 4. Also performed system maintenance duties using primarily SAS, UNIX scripts, and VAX DCL command/batch files.

Responsible for migration of standard programs and command files from VAX to UNIX environment. In this process, I was required to configure a UNIX environment to be as similar as possible to the VAX environment the users and programmers had grown accustomed to. Proficiency in UNIX script development was essential as well as an excellent understanding of how the SAS environment (e.g. config.sas, autoexec.sas, macro and format libraries, etc.) is established. As a result of my work, the learning curve and downtime of the statistics and programming groups was greatly minimized and nearly avoided altogether.

Developed, tested, implemented, and maintained an Oracle-to-SAS data interface using SAS/AF, SCL, MACRO and SQL/Pass-thru facility. System was designed to generate SAS datasets for use in development phase and SAS/Access views for generation of final tables, listings, graphics and reports. This was done to maximize speed and efficiency of development programming while minimizing disk space requirements.

Supervised the redesign of technically outdated standard output programs, i.e. programs generating listings and tables, which are submitted to the FDA (Food and Drug Administrations), for each clinical trial in an NDA (New Drug Application). Managed project team of several statisticians and statistical programmers, while providing guidance in programming techniques and development procedures.

Developed Searle’s first CANDA (Computer-Assisted New Drug Application). Received Searle’s ACE Award for this achievement.

G.D. SEARLE & COMPANY 01/1988 – 01/1990 (24 months)

Database Coordinator (Consultant) Skokie, IL

Responsible for creation of clinical study databases, maintenance of related programs and system interfaces using System 1032.

Developed a tracking system to monitor the study definition process utilizing 1032 and VAX/DCL command files. This system would monitor the progress of study definition from protocol development to completion of database.

Developed, tested, implemented, and maintained a System1032-to-SAS data interface using System1032 to generate database schemas. These schema files were used to load ASCII data files into SAS datasets using INFILE/INPUT datastep statements. Proficiency in developing VAX/DCL programs was needed to design a user-interface for this system. The interface allowed interactive or batch processing.

Additional Experience/Highlights

Designed, developed and established processes and scripts to support data migration projects for several large pharma clients surpassing expectations by meeting challenging timelines within budget.

Led a team to produce a metadata-driven, SAS-based framework to automatically produce artefacts (Edit Checks, SDTM and ADaM datasets, and TFLs (Tables, Figures and Listings)) on demand. Project included definition of metadata requirements, collaborative development of transformational metadata to support the artefact generation, design and development of the system itself, management of a global, cross-functional team; and, effective project management and communications to various levels of the contributing and client organizations.

Created, updated, and maintained GUI system used for entry of medication classes; maintained data dictionary and classification systems.

Managed teams of CRF developers, database developers, programmers and data management specialists, developing and implementing process improvement strategies.

Software Development Life Cycle – experienced with both Waterfall and Agile methodologies.

Gathered user requirements for new systems, generating functional requirements and defining detailed system and design specifications.

Led several systems validation projects around systems and SAS upgrades, macro library and tool/utility implementations.

Served as clinical trial programmer supporting clinical trial phases 1-4 across several therapeutic areas and indications, including regulatory submissions. Lead and key contributor to several NDA projects.

Developed, tested, implemented, and maintained programs, macros, and utilities (SAS, SQL, Perl, Shell/AWK scripting) for support of biometrics activities.

Used MS Project and Sharepoint to develop and manage project charts and timelines.

Therapeutic Experience

Addiction Prevention

Anti-infectives

Arthritis

Cardiovascular

Inflammation

Oncology

Pain Management

Education & Certifications

Information Systems/Computer Science, DePaul University, Chicago, IL

Java Developer Certification, DePaul University, Chicago, IL

SAS Certifications (V6, V8), SAS Institute

Technical Experience

Programming: SAS, SQL, C++, Java, Perl, VB/VBA, Shell Script

Platforms: Windows, Unix, MVS

Standards: CDISC: CDASH, SDTM, ADaM

Pain Management Publications & Presentations

Partial list of publications and presentations since 2019 (please note that all links may not be available/active):

Thomas Kalfas, Parveen Kumar, InformaConnect – Clinical Data Disclosure Conference, March 2023, Philadelphia, PA/US, “Humans and Machines Working Together to Fuel the Automation of Anonymization”.

URL: <Not Currently Available>.

Thomas Kalfas, PhUSE US Connect, March 2023, Emerging Trends, Orlando, Florida/US, “ET15: Introduction to Machine Learning Models, How to Train Them and What to Do if They Become Sassy”. URL: https://phuse.s3.eu-central-1.amazonaws.com/Archive/2023/Connect/US/Florida/PRE_ET15.pdf.

Thomas Kalfas, PhUSE Single Day Event (SDE), 2022, Boston, MA/US, “Tools to Solutions: Use of AI/ML to Support Automation”.

URL: https://phuse.s3.eu-central-1.amazonaws.com/Archive/2022/SDE/US/Boston/PRE_Boston02.pdf.

Thomas Kalfas, PhUSE EU Connect, 2021, (Virtual), “Software Demonstrations: Life Science Automated Solutions Empowered by AI & ML”.

URL: https://event.on24.com/wcc/r/3484583/1E5F02B28DEB4DEEFD17D36F6FA8C7E5. (Starts at 29:52)

Thomas Kalfas, PhUSE SDE, 2021, (Virtual), “Insight into the Growing Use of R, Shiny and Python”.

URL: https://phuse.s3.eu-central-1.amazonaws.com/Archive/2021/SDE/US/Virtual%20-%20Autumn/PRE_Americas21.pdf.

Thomas Kalfas, PhUSE SDE, 2019, Cincinnati, OH/US, “The Interactive Visualization – A Brand-new Way of Visualizing Your Data Using GraphDB”.

URL: https://phuse.s3.eu-central-1.amazonaws.com/Archive/2019/SDE/US/Cincinnnati/PRE_Cincinnnati04.pdf.

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