Lisa Kowarski Email & Phone Number

Washington, Dc, Us

Washington, Dc, Us

2500 Valby, Dk

Support development of new therapies by leading programming activities for clinical trials:• Serve as trial lead programmer and represent programming function on the clinical trial team for assigned trials• Direct vendor and internal team as applicable to prepare all programming deliverables and documentation for assigned trials, including SDTM, ADaM, and TLFs• Ensure integrity, consistency, adherence to standards, and well-structured, high quality data summaries for internal decision making and reporting to health authorities• Collaborate cross-functionally with statistics, clinical scientists, data management, medical, and operations colleagues to ensure data quality, fitness for purpose, and global understanding of study requirements to anticipate challenges and opportunities• Contribute to department and company-wide initiatives to improve efficiencies and increase capabilities

Armonk, New York, Ny, Us

Supported United States Food and Drug Administration (FDA) research initiatives:• Served as a technical project manager and lead data scientist for IBM's contract as the electronic health records (EHR) and linked administrative claims-EHR coordinating center and research partner for the FDA Biologics Effectiveness and SafeTy (BEST) Initiative.o Designed epidemiologic studies and constructed study protocols for studies on outcome identification, algorithm validation, and biologics safety and effectiveness.o Led implementation of protocols and feasibility analyses, including the development of programming specifications and oversight of programmers/data scientists to produce analysis datasets and presentations.o Implemented study protocols by writing and executing analysis SAS, R, and SQL code on claims and EHR data.o Interpreted study results in presentations, reports, and peer-reviewed manuscripts, in collaboration with various research partners in support of the BEST mission.o Applied knowledge of medical terminologies (e.g. ICD, NDC, LOINC, HCPCS, CPT, MedDRA, ATC) to lead multidisciplinary teams to develop rules-based algorithms for outcomes, covariates, and exposures.o Presented results at scientific workgroup meetings and contributed to conference proceedings.o Managed relationships with data partners, subcontractors, and client stakeholders.• Served as key personnel expert public health data analyst for a project to develop standards for submission of RWD.

Armonk, New York, Ny, Us

Supported FDA research initiatives:• Similar to Lead Data Scientist, Senior Managing Consultant responsibilities, with more support from senior staff.o Interpreted study results in presentations, reports, and peer-reviewed manuscripts, including providing a podium presentation at AMIA Annual Symposium 2022.

Us

Served as the lead statistical programmer and reporting statistician for multiple complex projects, leading the generation of reports, analysis plans, and charters, presenting reports to DMCs and clients, and managing multi disciplinary project teams:• Lead statistical programmer and reporting statistician to DMCs overseeing 15 clinical trials, including program-level DMCs overseeing up to 6 studies. • Lead statistical programmer and consulting statistician for a final analysis of a Phase 2 trial investigating a therapy for Huntington’s disease, including producing and validating CDISC-compliant ADaM datasets, leading discussions with the sponsor and partners regarding data and programming, contributing to the SAP, overseeing planned and post-hoc statistical analyses, and co-authoring the clinical study report and publications.• Consulting statistician and statistical programmer for over 5 clinical trials, including calculating sample size/power, designing and executing ad hoc statistical analyses, drafting SAPs and protocol statistical sections, and reviewing briefing books.• Planned, oversaw, and provided programming for studies in numerous therapeutic areas, including analysis datasets, tables, listings, and figures.• Drafted and reviewed data management documents, participated in UAT, and audited randomization and kit distribution.• Managed teams of programmers, including planning and oversight of all deliverables, ensuring timely execution of QA processes and delivery to timelines and budget.• Developed and validated SAS macros for general use.• Developed proposals, including pricing and budgets, and maintained statements of work.• Up to 5 direct reports at a time and served as a hiring manager for research staff.• Participated in corporate strategy meetings, improved programming documentation, and participated in writing standard operating procedures.• Presented at internal seminars to disseminate statistical, programming, and management expertise.

Us

Served as the lead statistical programmer and reporting statistician for multiple complex projects, leading the generation of reports, analysis plans, and charters, presenting reports to DMCs and clients, and managing multi disciplinary project teams:• Similar to Senior Biostatistician responsibilities, but without direct reports.• Trained new project managers on project leadership, client coordination, and resource management.

Us

Served as the lead statistical programmer, performed statistical programming and project management, and developed approaches to improve project efficiency in support of multiple clinical trials:• Managed statistical programming, teams, data reports, and finances for multiple DMC and consulting projects.• Provided statistical programming for over 10 studies, including as lead statistical programmer for 5 studies.• Participated in authorship of a publication reporting results of a Phase 3 trial.• Communicated project status and programming issues and reported results of consulting requests to clients.• Created general use SAS macros to make programming more efficient for my project teams. • Wrote and reviewed standard operating procedures and policies.• Developed a project management training module on leadership, client coordination, and resource management.• Continued to fulfill responsibilities listed under Statistical Programmer/Senior Research Associate.

Us

Prepared deliverables for committees comprised of expert clinicians and statisticians, including provision of statistical programming, and ensured timely execution of project deliverables:• Managed team, finances, and day-to-day research operations of projects in support of over 10 international clinical trials, primarily Phase 2/3, and managed statistical programming for one study. • Programmed analysis datasets (ADaM from SDTM and ADaM-like from native data models), tables, listings, and graphical displays using SAS software, and validated dataset and presentation programs written by biostatisticians and programmers. • Reviewed data transfer agreements and assured compliance of data received.• Validated structure and contents of a laboratory vendor’s pharmacokinetic results datasets for a Phase 3 oncology study and created blinded summaries to maintain sponsor blind while study was ongoing.• Functioned as the primary liaison with clients, DMC members, data management personnel, and programmers.• Trained and mentored new employees.• Developed proposals, including pricing and budgets, and negotiated and managed contracts.

Us

Provided administrative and programming support, ensured quality control, and prepared deliverables for the final analysis of a Phase 3 study and DMCs overseeing Phase 1-4 studies:• Managed day-to-day research operations of projects in support of 9 Phase 1-4 international clinical trials.• Contributed to report writing, review, and design, including preparation of table, figure, and listing shells for DMC reports and final analyses based on review of case report forms, study protocols, DMC Charters, and SAPs.• Completed SAS Programming 1: Essentials and Statistics Collaborative’s in-house SAS training.• Programmed SAS tables, listings, and figures and audited presentation programs written by biostatisticians and programmers.• Provided contracts administration, including proposal development and contract negotiation and management, in accordance with operational policies and legal requirements.• Coordinated delivery of confidential materials • Scheduled meetings and drafted meeting minutes• Acted as the primary liaison with clients and DMC members• Trained and mentored junior staff

Hamilton, N.Y., Us

Bachelor Of Arts, Psychology

Master Of Public Health - Mph, Epidemiology

Study Abroad