Principal Clinical Data Scientist

Boehringer Ingelheim • Ridgefield, CT • 10h ago

Description

POSITION ELIGIBLE FOR BENEFITS UNDER EMPLOYEE REFERRAL PROGRAM

Employer : Boehringer Ingelheim Pharmaceuticals, Inc.

Job Title : Principal Clinical Data Scientist

Location : 900 Ridgebury Road, Ridgefield, CT 06877 (Telecommuting permitted: work may be performed in any location in the U.S.)

Job Duties : Lead and oversee the design, transformation, analysis, and reporting of complex studies/projects such as complex phase I-IV clinical trials or projects with established company experience and support complex international projects. Lead and oversee the design, transformation, analysis, and reporting of other data from the clinical drug life cycle process, such as registries and real-world data bases, with respect to a specific use case or project/asset. Present compelling validated stories regarding data science aspects within and outside the company. Ensure data transformation and analysis specifications to ensure completeness, correctness, and adherence to department guidelines and SOPs, as well as to applicable GxP requirements. Guide and/or lead other colleagues, internal and external customers, and external providers on data science related tasks. Ensure cross-functional and team-based working within Biostatistics and Data Sciences (BDS) and with other units at the company. Support the fostering of innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes, and predictive models. Interact with various other functions and roles within and outside of BDS, leading and/or having strategical impact regarding substance level. Know, understand, and implement international regulations and guidelines for good clinical and statistical practice from all ICH regions, company processes, and SOPs that govern clinical development and other regulations. *Telecommuting permitted: work may be performed in any location in the U.S.

Work Schedule : 40 hours per week (8:00am to 5:00pm)

Description (cont'd)

Job Requirements : Master's degree (U.S. or foreign equivalent) in Statistics, Data Science, Math, Computer Science, Information Technology, Technology Management, Chemistry, Pharmaceutical Science, or a related field and six (6) years of experience in the job offered or in a related role OR Bachelor's degree (U.S. or foreign equivalent) in Statistics, Data Science, Math, Computer Science, Information Technology, Technology Management, Chemistry, Pharmaceutical Science, or a related field and seven (7) years of experience in the job offered or in a related role. Must have six (6) years of experience using SAS macro language, SAS SQL, and SAS Stat. Must have four (4) years of experience working in the Central Nervous System (CNS) Therapeutic Area on the analysis and reporting of electronic patient reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA). Must have experience with: leading New Drug Application submission activities for the Food and Drug Administration (FDA)-Integrated Summary of Safety/Integrated Summary of Efficacy/Bioresearch Monitoring Program package and managing additional post-filing requests; providing functional expertise to support the FDA communication package (Type C & Type B meetings) and being a point of contact as a subject matter expert in this area; planning, transforming, analyzing, interpreting, and reporting data in clinical trials or data from other sources in clinical research and development; using Clinical Data Standards, including Clinical Data Interchange Standards Consortium (CDISC)-Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM); using Medical Dictionary for Regulatory Activities (MedDRA) and WHODrug dictionary; performing User Acceptance Testing for databases; and, developing the scope of work for statistical programming tasks and subsequent vendor selection. 10% domestic and international travel required.

All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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