Thomas Neitmann

Experience

• 

  Charité - Universitätsmedizin Berlin

  Nov 2017 - Mar 2019

  Research Associate Biomechanics

  • Performed human subject studies in both healthy and orthopedic patient populations using state-of-the art biomechanical research tools including 3D motion capture and surface electromyography• Administered both data capture in the Charité's motion analysis laboratory and subsequent data management• Developed software to integrated data from various measurement tools and synthesized those data to produce a detailed biomechanical description of the subject's motion pattern in order to evaluate the effect of various treatment interventions• Performed statistical analyses of biomechanical waveforms using Statistical Parametric Mapping• Lectured in the Medicine degree program on biomechanics research methods and the role of physical activity in preventing disease Show less

• 

  CCDRD AG

  Apr 2019 - Aug 2019

  Statistical Programmer

  • Performed statistical analyses of late phase clinical trials and bioequivalence studies in accordance with statistical analysis plans, regulatory guidelines (e.g. ICH GCP, ICH E9), and SOPs• Developed SAS macros to create CDISC compliant SDTM and ADaM datasets for FDA submissions• Created tables, listing, and figures for clinical study reports• Created SDTM/AdaM define.xml, Study Data Reviewer's Guide (SDRG) and Analysis Data Reviewer's Guide (ADRG)

• 

  Roche

  Sept 2019 - Apr 2023

  • In my role as Product Owner of {admiral}—an open-source R package for ADaM dataset creation—I am responsible for maximizing the value the development team adds to the business• As Code Collaboration Lead I am responsible for driving collaborations with other pharmaceutical companies on the development of open-source R packages• I am leading a cross-company effort to submit ADaM datasets created in R to FDA as part of the R Consortium's submissions working group• As a subject matter expert I am contributing to defining new standard ways of working for our next generation statistical computing environment which leverages R as the backbone for clinical reporting• I am leading the development of a Coursera course on "Hands on Clinical Reporting in R" that will introduce Data Scientists without experience working in the pharmaceutical industry to clinical trial data analysis and how to leverage open-source R packages for all aspects of the clinical reporting pipeline• I am responsible for conducting technical interviews with an emphasis on R for all new Analytical Data Scientist/Statistical Programmer hires at the Basel site Show less • Lead a cross-company team of over 10 developers from Roche and GSK in the development of an R based solution for deriving ADaM datasets. By following agile development and software engineering best practices we developed an open-source R package that filled the largest gap in the R based clinical reporting pipeline. The package is available from CRAN.• Successfully lead two high-profile molecule teams (consisting of 10 programmers in total) through their first attempt at reporting clinical trials using R. This resulted in one of the teams receiving a gold medal in the "statistical programming Olympic games" for producing 100% of outputs in R.• Spearheaded the development of an in-house R package to streamline the creation of TLGs in R which is being used by more than 10 different molecule teams across all Roche sites (including for health authority fillings)• Taught a series of R courses aimed SAS programmers to drive the adoption of R within the organization forward. Courses were highly sought after—more than 150 programmers from all Roche sites and external business partners attended.• Acted as a super user for NEST—Roche's R based clinical reporting toolbox. Aided programmers in the adoption of R Shiny based interactive data exploration tools in several key late-stage trials across multiple therapeutic areas. Show less • Provided end to end statistical programming support in planning, specifying, designing, developing, and implementing statistical software solutions for the reporting and analysis of late-phase oncology clinical trials• Concurrently acted as a lead programmer for two late-phase oncology studies managing 3 and 2 other programmers, respectively• Developed interactive web applications using R Shiny to enable internal stakeholders (Safety, Biostatistics, Clinical Science) to explore and analyze clinical trial data• Acted as a SME for enableR—a validated R environment for producing outputs for regulatory submissions• Established the R Code Clinic—a forum for Statistical Programmers to discuss any topic relating to analyze clinical trial data using R Show less

  • Senior Data Scientist

    May 2022 - Apr 2023

  • Statistical Programmer Analyst

    Sept 2020 - Apr 2022

  • Statistical Programmer

    Sept 2019 - Aug 2020
• 

  Denali Therapeutics

  May 2023 - now

  Associate Director, Data Science