Dr. Lauer Research

Dr. Lauer Research

Curriculum Vitae

Professional experience, education, selected training, and publications.

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Personal

Name
Dr. Sabine Lauer (nee Ricker)
Languages
German native speaker, fluent in English and French (both spoken and written)

Professional Experience

since Apr 2010
Dr. Lauer Research, Neu-Isenburg, Germany Freelance Biostatistician
Aug 2006 - Mar 2010
Accovion GmbH, Eschborn, Germany Senior Biostatistician
Jan 2006 - Jun 2006
Merz Pharmaceuticals GmbH, Frankfurt/Main, Germany Biostatistician
Dec 2002 - Dec 2005
Accovion GmbH, Eschborn, Germany Biostatistician
Apr 2001 - Nov 2002
SECUDE GmbH, Darmstadt, Germany Consultant for Cryptographic Applications

Study statistician for various clinical trials (phase II-IV and observational studies, including trials with an adaptive design), involved in all statistical activities such as

  • Protocol writing, (e)CRF design, data surveillance
  • Writing of statistical analysis plans
  • Design, programming, validation and statistical review of tables, listings, and graphs
  • Writing of clinical study reports, lay summaries, annual safety reports and publications

Further experience

  • Meta-analyses/Integrated summaries
  • Bayesian modeling of dose-response relationship in a dose escalation and expansion trial (Phase Ia/b)
  • Interactions with regulatory authorities including preparation of submission dossiers, preparation and attendance of meetings, response to questions
  • Analyses evaluating the predictive and prognostic value of biomarkers for cardiac events and development of a heart failure risk score
  • Principal stratum analyses for immunogenicity (anti-drug-antibodies)
  • Prediction of probability of final trial success after interim analysis
  • Event-prediction
  • Independent statistician as well as statistical member of data monitoring committees

Project leader of numerous projects with responsibility for the following main tasks:

  • Coordination and leadership of team members
  • Key contact person for client requests
  • Financial tracking and management of timelines and resources

Experience as a statistician and/or project leader in various indications, including lung cancer, hemophilia B, breast cancer, cardiovascular disease, fabry disease, pain, migraine, epilepsy, spasticity, multiple sclerosis, osteoarthritis, dementia, colon cancer, and diabetes.

In-depth programming skills in SAS/SAS-MACRO and advanced skills in R.

Education

1999 - 2001
Johann Wolfgang Goethe-University, Frankfurt am Main, Germany Ph.D in Mathematics
1998 - 1999
Oregon State University, Corvallis, Oregon, USA Research stay at the Department of Mathematics
1996 - 1999
Studienstiftung des deutschen Volkes Scholarship holder
1993 - 1998
Johann Wolfgang Goethe-University, Frankfurt am Main, Germany Masters degree in Mathematics

Selected Training and Conferences

2026
IBS Webinar: Is repeated Bayesian interim analysis consequence-free?
2025
EFPSI Regulatory statistics workshop (virtual attendance)
2024
Arbeitsgruppe Pharmazeutische Forschung: München, Germany Drug development in rare diseases
2023
Basel Biometric Section (BBS) Virtual Seminar Quantification of risk: ask the right questions or time to apply the estimand framework to safety
2022
Basel Biometric Section (BBS) Virtual Seminar Machine learning in clinical drug development
2021
Arbeitsgruppe Pharmazeutische Forschung Virtual Workshop Breakthrough Therapies
2020
Basel Biometric Section (BBS) Virtual Seminar Impact of COVID-19 on clinical trials
2019
Austro-Swiss Region of the international biometric society and Medical University of Vienna Workshop on Bayesian Clinical Trials
2018
64. Biometrisches Kolloquium, Goethe-Universität Frankfurt/Main Biometrie: Gelebte Vielfalt
2017
European Federation of Statisticians in the Pharmaceutical Industry (EFPSI): Basel, Switzerland Workshop on Regulatory Statistics
2017
International Biometric Society (IBS): Berlin, Germany Analysis of multiple event-times: recurrent events and combined endpoints
2015
PhUSE annual conference: Vienna, Austria Best presentation award in the Statistics & Pharmacokinetics stream for “Adjusting long-term efficacy estimates when patients cross over to experimental treatment”
2014
Arbeitsgruppe Pharmazeutische Forschung: München, Germany Subgroup analyses and experiences with the missing data guideline
2013
International Biometric Society (IBS): Berlin, Germany Multiple testing procedures in clinical trials
2010
Statisticians in the Pharmaceutical Industry (PSI) E-Learning James Carpenter Multiple Imputation Course
2009
Medical and Pharmaceutical Statistics Research Unit (MPS): Lancaster University, United Kingdom Adaptive and bayesian methods in clinical research
2007
Multiple Comparison Procedures (MCP): Vienna, Austria 5th international conference on multiple comparisons
2006
International Biometric Society (IBS): Berlin, Germany Workshop on adaptive designs
2005
IBS: Universität Halle, Germany Tutorial Interim monitoring of clinical trials
2004
MPS: University of Reading, United Kingdom. Statistical analysis of categorical data
2003
MPS: University of Reading, United Kingdom. Meta-analysis of controlled clinical trials

Selected Publications

  1. Anker et al. “Empagliflozin in patients with type 2 diabetes mellitus and chronic obstructive pulmonary disease”, Diabetes Research and Clinical Practice (Apr 2022)
  2. Kong et al. “Weighted approach for estimating effects in principal strata with missing data for a categorical post-baseline variable in randomized controlled trials”, Statistics in Biopharmaceutical Research (Jan 2022)
  3. Ferreira et al. “Cardio/Kidney Composite End Points: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial”, American Journal of Hypertension (Dec 2021)
  4. Ferreira et al. “Empagliflozin for patients with presumed resistant hypertension: a post hoc analysis of the EMPA-REG OUTCOME trial”, Journal American Heart Association (Dec 2020)
  5. Ferreira et al. “Metabolic syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a post hoc analysis of the EMPA-REG OUTCOME trial”, Cardiovascular Diabetology (Nov 2020)
  6. Lidbrink et al. “A real-world study of cardiac events in >3700 patients with HER2-positive early breast cancer treated with trastzumab: final analysis of the OHERA study.”, Breast Cancer Research and Treatment (Nov 2018)
  7. Gligorov J et al. “Switching between intravenous and subcutaneous trastuzumab: Safety results from the PrefHer trial”, Breast. (Aug 2017), pages 89-95
  8. Cameron D et al. “11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial”, Lancet (Mar 2017), pages 1195-1205
  9. Zardavas D et al. “Role of Troponins I and T and N-Terminal Prohormone of Brain Natriuretic Peptide in Monitoring Cardiac Safety of Patients with Early-Stage Human Epidermal Growth Factor Receptor 2-positive Breast Cancer Receiving Trastuzumab: A Herceptin Adjuvant Study Cardiac Marker Substudy”, Journal of Clinical Oncology (Mar 2017), pages 878-884
  10. Sabine Ricker “Symmetric Fuchsian quadrilateral groups and modular embeddings”, Quart. J.Math. 53 (2002), pages 75-86