Description

Job Duties: Responsible for transforming, analyzing and reporting phase I-IV clinical trials and/or other data from research and development like registries and real-world data bases with respect to a specific use case or project/asset. Present compelling validated stories regarding data science aspects to Biostatistics Data Science (BDS) colleagues. Ensure data transformation and analysis specifications to ensure completeness, correctness and adherence to department guidelines and SOPs as well as to applicable GxP requirements. Support colleagues on data science related tasks. Participate in cross-functional BDS internal working-groups and drive/plan relevant data science aspects. Understand, and implement international regulations and guidelines for good clinical and statistical practice from all ICH regions, the various international guidelines on clinical development, including statistical methodology, for TA-related disease areas, and BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g., Clinical Development Plan). Understand complex problems within clinical research and development, taking into account needs and requirements of other units and departments. Keep abreast of data science and in particular new transformation and analyzing solutions and innovative processes/tools within BI.

Role and Responsibilities

• Job Requirements: Bachelor’s degree (US or foreign equivalent) in Statistics, Data Science, Math, Computer Science, Information Technology, Technology Management, or a related field and three (3) years of experience in the job offered or in a related role. Must have three (3) years of experience with: planning, transforming, analyzing, interpreting, and reporting data in clinical trials or data from other sources in clinical research and development; and performing quality control steps throughout the Program Development Life Cycle (including final report). Must have two (2) years of experience with: utilizing Clinical Data standards such as CDISC – SDTM & ADaM, WHO & MedDRA; statistical concepts in support of analyses and reporting of clinical trials; working as a lead programmer on multiple projects across various therapeutic areas; and the oncology therapeutic area clinical data analysis with the knowledge of RECIST 1.1 criteria for solid tumor. Must have one (1) year of experience with: SAS macro language, SAS SQL, and SAS Stat; Pooled Analysis such as Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE); working and reviewing submission packages, which includes define.xml, SDTM annotated CRF, and reviewer’s guides; and developing customized interactive visualization reports, dashboards, and charts using data visualization tools. *Telecommuting permitted: Work may be performed within normal commuting distance from the Boehringer Ingelheim Pharmaceuticals, Inc. office in Ridgefield, CT. Work Schedule: 40 hours per week (8:00am to 5:00pm)