Driving Evidence Strategies
Biostatistician & Epidemiologist
I am Thomas Heisser, an Independent Consultant with expertise in the areas of HTA & Market Access, Biostatistics, Epidemiology, and Data Science. I live in Heidelberg, Germany.
Expect strong motivation and a proactive personality
My work is motivated by the great potential of the life science disciplines to make a lasting impact on patients‘ lives. This has driven my passion for health science research, technology transfer and public policy since I started my career in 2014. I believe in lifelong learning and constantly strive for professional and personal development and growth. My personality is very proactive and results-oriented, with a strategic mindset and strong cross-functional leadership skills at the core.
Expect high level performance
My qualifications include degrees in Biostatistics (M.Sc., University of Heidelberg), Epidemiology (PhD, summa cum laude, University of Heidelberg, and M.Sc., University of Munich), and Political Science (B.A., University of Wuerzburg), and a proven track record of professional achievements in a multitude of projects across industry and academia.
My aim is to exceed your expectations and provide results that not only meet the highest quality standards but also fulfil your individual requirements. I look forward to working with you on your project and demonstrating my expertise, reliability and creativity.
Want to get in touch?
My key competences
Health Technology Assessment & Market Access
- PICO development, market authorization scenario planning, development of target product profiles and key value messages
- Oversight and preparation of payer value dossiers on the global, European or affiliate level, including dossiers for JCA/CA (EUnetHTA) and Early Benefit Assessment (AMNOG)
- Preparation of payer advice briefing books, participating in advice meetings as HTA/Market Access, or Biostatistical expert
Biostatistics, data analysis and modelling
- Development of Statistical Analysis Plans and TLFs, focus on medical affairs/payer level requirements
- Strategic input, e.g. development of estimand strategies, missing value strategies, sensitivity analysis
- Selection of suitable evaluation methods and statistical models, including for complex approaches and ITCs
- Review or writing of methodology and results sections
Epidemiology
- Support in planning, implementation and interpretation of observational studies, e.g. healthcare claims data or registry data
- Development of patient funnels, e.g. for forecasts or budget impact analysis
- Confident handling of principles of evidence-based medicine, epidemiological measures and methods
Project management
- Expert planning, kick-off, management and completion to achieve the project goal on time, e.g. data or strategy workshops, TLF output delivery planning
- Experienced in interim management, e.g. for HTA/HEOR, Market Access, or Biostatistics functions
Medical and Scientific Writing
- Track record of first-authorship scientific publications
- Preparation of introduction, methodology, results and/or discussion sections in a concise and clearly understandable form
- Style, degree of complexity and depth of details targeted to journal or other audience (e.g., medical or payer community)
Scientific communication
- Identification and targeted communication of key messages
- Customised presentations and presentation formats depending on the audience
HTA & Market Access | example projects
Project Manager Health Technology Assessment – Prostate Cancer
Responsibilities
- Responsible project manager for the preparation of two payer value dossiers and written statements, including evidence and analyses strategy, coordination of cross-functional team and management of vendors
- Co-developed oral hearing strategy and represented client in oral hearing, focus on methodological topics (alternative analysis for overall survival endpoint)
Project Manager and Statistical Support Health Technology Assessment – Lupus
Responsibilities
- Responsible project manager for the payer value dossier and written statement, with additional tasks in statistics
- Planned and implemented indirect treatment comparisons for submitted evidence package (Bucher method, implemented in R)
- Represented client as methods/statistics expert in oral hearing
Biostatistics | Example Projects
Statistician for Health Technology Assessment – Vasomotor Symptoms
Responsibilities
- Development of post-hoc payer analysis plan covering full re-analysis of four randomized trials and two meta-analyses, including TLF shells
- Programming vendor contact point; quality control using R (e.g., library metafor)
- Ad-hoc assessments, e.g., on preferable test statistics or hedges’g calculation
- Production of figures for submission using R (e.g., libraries forestplot, ggplot2)
Statistician for Health Technology Assessment – Urothelial Cancer
Responsibilities
- Development of post-hoc payer analysis plan for re-analysis of a randomized trial, including complex methods to address lack of a required maintenance therapy in the control arm
- Provided bias assessment of various approaches, including imputation methods and ITC
- Provided key input in overall HTA strategy with respect to payer body’s requirements
Epidemiology | example projects
Development of Patient Funnels – Solid Tumors
Responsibilities
- Supervised and implemented targeted analyses using healthcare claims data (InGef), panel data (Disease Analyzer), and literature data to derive the expected number of patients in scope for treatment, including development of analysis plan, management of vendors, and medical writing
Treatment Costs for Colorectal Cancer (Research Project)
Responsibilities
- Designed and published a population-based study on health insurance data, including development of analysis plan, management of vendors, production of graphical outputs, and medical writing
Systematic Review and Meta-Analysis – Colorectal Cancer (Research Project)
Responsibilities
- Designed, conducted and published a systematic review and meta-analysis on colorectal cancer screening intervals, including definition and implementation of search strategy, bias assessment, statistical analysis and medical writing
Data Science | example projects
Development and Validation of a Markov-based Simulation Model – Colorectal Cancer
(Several Research Projects)
Responsibilities
- Development lead of the COlorectal Cancer Multistate SImulation MOdel (COSIMO), a Markov-based simulation tool to simulate outcomes of colorectal cancer screening strategies, including complex pathways reflecting time-in-model and time-in-state required to simulate life-long screening strategies
- Validation of COSIMO outcomes by calibrating the model to match real-life data from RCTs, cross-section data, and registry data
Development of the Colorectal Cancer Prevention Calculator, a R-Shiny Web Application (Research Project)
Responsibilities
- Development lead of a R-Shiny Web Application to depict the age-and sex-specific impact of demographic aging on expected colorectal cancer cases up to the year 2050, as well as the mitigating effects of increases in colorectal cancer screening uptake
Prizes & Awards
Selected publications
Heisser T, Kretschmann J, Hagen B, et al. Prevalence of Colorectal Neoplasia Ten or More Years after a Negative Screening Colonoscopy: Registry-based study based on 120,000 repeat screening colonoscopies. JAMA Internal Medicine. 2023;183(3):183-190.
Heisser T, Hoffmeister M, Tillmanns H, Brenner H. Impact of demographic changes and screening colonoscopy on long-term projection of incident colorectal cancer cases in Germany: a Modelling Study. Lancet Regional Health: Europe 2022; 20
Heisser T, Möllers T, Cardoso R, et al. Earlier screening colonoscopy for men: the need for complementary screening offers at older age. Dtsch Arztebl Int 2021;118:691–2. doi:10.3238/arztebl.m2021.0266
Heisser T, Guo F, Niedermaier T, et al. Low Risk of Advanced Neoplasms for up to 20 Years After Negative Colonoscopy Result: Potential for Personalized Follow-up Screening Intervals. Gastroenterology 2020;159:2235-2237.e4. doi:10.1053/j.gastro.2020.08.003
Heisser T, Weigl K, Hoffmeister M, et al. Age-specific sequence of colorectal cancer screening options in Germany: A model-based critical evaluation. PLoS Med 2020;17:e1003194. doi:10.1371/journal.pmed.1003194
Heisser T, Peng L, Weigl K, et al. Outcomes at follow-up of negative colonoscopy in average risk population: systematic review and meta-analysis. BMJ 2019;367:l6109. doi:10.1136/bmj.l6109
Full list of publications: https://pubmed.ncbi.nlm.nih.gov/?term=Heisser+T