Lucyna provides strategic and hands-on consulting in epidemiology, biostatistics and real-world evidence for the pharmaceutical, biotechnology, and medical device industriesREAL-WORLD EVIDENCEReal-world evidence generation strategizing:- RWE feasibility and strategy assessments and planning to support submissions- RWD to create external control armsCommercialization and target opportunity planning for new indications or patient profiles using RWD (mainly through well-designed studies using claims databases)Database studies: Extensive experience planning (protocol writing and working with multidisciplinary teams) and executing analyses in a variety of claims, EHR, and registry databases including: MarketScan, Symphony, Optum, Premier, HealthVerity, TriNetX, Medicare claims (and SEER); International healthcare databases: THIN (UK), Medisoft, GKV (German), CPRD (UK), Medisoft (UK)EPIDEMIOLOGY AND BIOSTATISTICSStudy execution: Study/trial design development, protocol and statistical analysis plans, IRB approval, statistical programming and analysis.Statistical Analysis: - Organize clinical trial data into SDTM and ADaM data sets preparatory for FDA submissions. Perform analyses on said ADaM data sets.- Provide team leadership and programming oversight pursuant to the completion of tables, listings, and figures (TLF) shells across a variety of study typesTherapeutic areas: Cardiovascular, CNS, Diabetes, Musculoskeletal, Nephrology, Neurology/neuroscience (epilepsy, sleep, PTSD and other psychological disorders), Oncology (breast, lung, leukemia, skin, lymphoma, prostate, digestive tract) Ophthalmology, and respiratory/immune-inflammatory, Rheumatology.Four ways that we can help:- Project-base consulting (per SOW)- Hourly/Ad-hoc consulting/Retainer- Gap filling/staffing- PartneringConnect with Dr. Nelms to learn more!

• Provide senior leadership and direction for a thriving startup specializing in the execution of real-world evidence studies through a revolutionary digital clinical trial management platform (ClaimIt).• Oversee the design (through Protocol and SAP development) and implementation of all statistical analyses pursuant to TLF and CRS deliverables for all clinical studies across the Americas, Asia, Europe, and Australia.• Supervise senior and junior statisticians as direct reports.• Provide consultation to Project Managers, Data Management, Scientific Affairs, and senior leadership on all matters related to biostatistics.• Provide conceptualization and direction for digital product development pursuant to analytics task automation within ObvioHealth’s proprietary clinical trial platform (ClaimIt).• Participate in a variety of business development activities including networking, proposal development, client meetings/presentations, negotiations, and bid defenses.• Partner with the CEO to ensure the implementation of his vision for the company.

• Serve as a co-instructor in UNC’s graduate-level Introduction to Epidemiology course, responsible for day-to-day contact with 30 students.• Conduct live internet-based meetings and office hours on a weekly basis.• Assist in developing course assessment materials (assignments, exams, critiques, etc.)• Develop rubrics for and grade portions of at least 130 copies for three exams.• Assist the lead faculty member on any grade disputations or other clarifications pertinent to the course.• Develop dissertation project examining the association between unemployment change and homicide inside and outside of the workplace.• Perform an extensive literature review on the effect of economic factors on homicide in the workplace and interpersonal violence.• Perform tasks as needed as part of the Oak Ridge National Laboratory, occupational mortality, Asbestex, and JUMP ACL studies.• Principal investigator in Poisson analysis of unemployment level change and homicide as well as a case-crossover study of transient unemployment level change and workplace homicide. Charged with study conceptualization, data gathering, cleaning and analysis, report and manuscript writing. First author on tow or more manuscripts.• Develop research proposal and restricted data agreement to satisfy CDC requirements.• Construct and manipulate, and analyze data sets of all sizes and study types in SAS. • Formulate statistical models by discovering confounding variables and effect modifiers in epidemiological studies.• Advanced methodological and subject-matter specific training pertinent to environmental, occupational, and injury epidemiology.• Develop reports and manuscripts for three studies.

• Coordinate Safe Communities injury prevention grant with the goal of raising traffic safety awareness and seatbelt use in the Barren River District.• Work closely with health department, hospital, and high school personnel in Barren County, Kentucky to develop interventions and campaigns for traffic safety.• Collaborate with law enforcement, county judge executives, and Students Against Destructive Decisions state advisors to assure the completion of grant objectives.• Organize and analyze injury and hospital admission data in SPSS.• Translate data into presentation form to be given to local stakeholders and BRDHD website visitors.• Develop the Barren River District Health Department Quality/Performance Improvement Plan using the Plan-Do-Study-Act model.• Train all health department staff including directors, supervisors, program coordinators, and other staff on new performance improvement standards.• Act as National Public Health Week Committee Chair organizing a climate change awareness campaign for the Barren River District.• Design brochures, posters, fact sheets, and other materials.• Create online surveys; collect and analyze results.• Respond to all data requests from clinicians, stakeholders, and the general public.