Ted Lystig, Ph.D., Fasa Email & Phone Number

Palo Alto, California, Us

Global head of the Biostatistics, Statistical Programming, and Data Management functions across BridgeBio. Provided critical input to data analytical strategy and execution in the context of preparing marketing applications for regulatory submission in the US, EU, UK, and other markets. Built and grew the various Biometrics functions to accelerate clinical development for multiple BridgeBio subsidiaries in therapeutic areas including transthyretin amyloid cardiomyopathy, autosomal dominant hypocalcemia type 1, hyperoxaluria, limb-girdle muscular dystrophy type 2i, and recessive epidermolysis bullosa. Critically reviewed multiple development programs as part of both the company's Clinical Advisory Board and Protocol Review Committee. Evaluated the strengths and weaknesses of studies from potential acquisition targets, providing summary assessments to the CEO and members of the Board of Directors.

Minneapolis And St. Paul, Minnesota, Us

Collaborated with faculty members and students to develop and publish advances in Bayesian adaptive designs for the medical device setting. Served as a member of the Faculty Search Committee for the Division prior to initial appointment. Acted as mentor for graduate students in the Division of Biostatistics. Frequent speaker, educator, and organizer at major international statistics meetings.

Minneapolis, Mn, Us

Global leader of the Biostatistics function for Medtronic. Sponsor and Chair of the Biostatistics Leadership Council, which consists of group leaders of biostatisticians across the company. Established and grew own central Corporate Biostatistics team from a single individual to a team of 16. Drove development and external regulatory endorsement of a novel Bayesian discount prior methodology for adaptively determining the proper amount of weight to give an historical data source combined with a current ongoing trial. Initiated and led the MDIC working group on External Evidence, which will develop a catalog of (non-exhaustive) case examples detailing supported methods for different data types (e.g., RWD, M&S) to meet certain objectives, as well as presenting agreed upon key steps for interactions between sponsors and regulators when working with external data. Worked directly with regulators as an active member of two separate IMDRF workstreams (Registries and Clinical Evidence) to advance sound clinical trial methods, especially for applications involving real world evidence. As a Steering Committee member, guided the Clinical Trials Transformation Initiative (CTTI) to account for Medtronic’s medical device manufacturer perspective in projects such as Single IRB, Mobile Clinical Trials, Real World Evidence, and Registry Trials. Created, promoted, and managed the Medtronic Clinical Grand Rounds to share lessons learned, provide a venue for dissemination of best practices, discuss issues of broad interest to the Clinical Research function, and build appreciation of the Clinical Research discipline. Maintained and enhanced the positive image of Medtronic statistics both internally and externally through consulting, presentations, scholarship, and professional networking. Continued previous roles with the Clinical Council, Global Clinical Research Excellence Award, and Medtronic Statistics Conference.

Minneapolis, Mn, Us

Provided leadership through influence for 100+ statisticians and statistical programmers across various Medtronic organizations. Promoted and supported the use of robust statistical and research design methods in clinical research throughout the company. Directly evaluated statistical aspects of key clinical programs (design, conduct, analysis, and interpretation). Founded and chaired the Biostatistics Advisory Group for providing a consistent process of statistical review of important trials across Medtronic. Chaired the organizing committee of the annual Medtronic Statistics Conference each year. Developed a Clinical Trialist Program together with the University of Minnesota for increasing the technical competency of non-statisticians in the Clinical function. Determined appropriate modern statistical methodology to be implemented in Medtronic's post-approval network. Regularly mentored statistical professionals across the company. Served as the company's primary statistical representative for key interactions with regulatory agencies and external subject matter experts.

Ingelheim Am Rhein, Rhineland-Palatinate, De

Served as project statistician overseeing international development plans in the areas of allergic rhinitis, asthma and chronic obstructive pulmonary disease (COPD). Co-statistical lead for the submission of a new drug application (NDA) for a COPD drug program. Worked as trial statistician designing and analyzing respiratory therapy area studies in multiple phases of development (I, II, III). Provided statistical expertise for interactions with regulatory agencies and external key opinion leaders. Active biostatistical resource for the company (such as for meta-analysis and mixed models repeated measures applications), ensuring scientific integrity in the application of statistical methodology to clinical trials. Responsible for statistical content of secondary publications based on the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial. Recruited new departmental staff members at major statistical conferences. Hiring manager for summer interns in the department.

Cambridge, Cambridgeshire, Gb

Designed and analyzed randomized clinical trials in the areas of obesity, diabetes, metabolic syndrome, and functional gastrointestinal disorders. Worked with researchers in both the Research Center for Endocrinology and Metabolism and the Deparment of Body Composition and Metabolism at the Sahlgrenska University Hospital in Gothenburg, Sweden. Delivered statistical support through consulting, presentations, and publications for a wide range of clinical and pre-clinical projects for these academic and medical researchers. Lead the statistical analyses of data from the Swedish Obese Subjects (SOS) study. Served as local expert in dependent longitudinal data and complex power calculations. Developed and applied novel statistical methods for the analysis of complex data, such as time course microarray experiments. Trained other staff in the proper methods of analyzing dependent longitudinal data.

Gothenburg, Sweden, Se

Developed methods and software for improved analysis of epistasis (interaction) in genome scans for quantitative trait loci (QTL). The methods involve application of permutation testing and the estimating function bootstrap to the log odds score statistics from genome wide scans. Calculation of threshold values and adjusted p-values with the new programs are performed several orders of magnitude faster than with the best previously available methods. Furthermore, the new methods permit the natural comparison of complex models, such as two loci epistasis to two loci additivity. The methods may be applied both to inbred line crosses in experimental organisms and to human genetics studies with many independent pedigrees. Partially funded by pharmaceutical companies Arexis and AstraZeneca.

Seattle, Wa, Us

Collaborated with medical and epidemiological researchers in the Human Papillomavirus Working Group. Projects included modelling progression and regression of precancerous cervical lesions, determining the infectivity of human papillomavirus in a cohort of university women and their partners, modelling error rates in polymerase chain reaction (PCR) experiments, and evaluating the impact of false test results in vaccine efficacy studies.

Seattle, Wa, Us

Member of the Methodology of Community-Based Evaluation Studies working group. Collaborated with public health and health services professionals. Projects included researching the historical basis for modern-day pooling analyses of community intervention studies and assessing the impact of pooling community-level data for a range of study designs.

Postdoctoral Fellow, Statistical Genetics

M.S., Ph.D., Biostatistics

B.A., Mathematics, Statistics

Semester In The Pacific Northwest

Education record