Principal Clinical Data Scientist

BioCT Innovation Commons; Ridgefield (CT); Remote; USD 130,000 - 170,000; Full time

Job summary

A leading company seeks a Principal Clinical Data Scientist to lead clinical data analysis and reporting for phase I-IV clinical trials. The role involves overseeing complex projects, ensuring compliance with regulations, and promoting collaboration across functions. Candidates must possess advanced skills in SAS and significant experience in data management, particularly within the CNS Therapeutic Area.

Benefits

Employee referral program eligibility

Telecommuting permitted

Qualifications

• 6+ years of relevant experience with Master's or 7+ years with Bachelor's degree.
• Experience in CNS Therapeutic Area analyzing ePRO and eCOA.
• Must lead FDA submission activities and have knowledge of CDISC standards.

Responsibilities

• Lead design and reporting of complex clinical studies/projects.
• Manage data from clinical drug life cycle for specific use cases.
• Present validated data science stories and ensure compliance with regulations.

Skills

SAS macro language

SAS SQL

SAS Stat

Data Analysis

Clinical Trials

Education

Master's degree in Statistics, Data Science, Math, Computer Science

Bachelor's degree in related field

Job description

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 phase I-IV clinical trials or projects with established company experience, including support for complex international projects. Manage data from the clinical drug life cycle, such as registries and real-world databases, for specific use cases or assets. Present validated data science stories internally and externally. Ensure data transformation and analysis meet department guidelines, SOPs, and GxP requirements. Guide colleagues, internal and external stakeholders, and providers on data science tasks. Promote cross-functional collaboration within Biostatistics and Data Sciences (BDS) and other units. Support innovative digital approaches for sophisticated solutions, predictive models, and process improvements. Interact with various functions, providing strategic input on substance level. Comply with international regulations and guidelines for good clinical and statistical practice from all ICH regions, adhering to company processes and SOPs governing clinical development and regulations.

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

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 related field, with six (6) years of relevant experience OR Bachelor's degree (U.S. or foreign equivalent) in the same fields with seven (7) years of relevant experience. Must have six (6) years of experience with SAS macro language, SAS SQL, and SAS Stat. Must have four (4) years of experience in CNS Therapeutic Area analyzing and reporting electronic patient-reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA). Experience with: leading FDA submission activities (e.g., ISE, ISE, BLA), supporting FDA communication packages, serving as a subject matter expert, data analysis and reporting in clinical trials, using CDISC standards (SDTM, ADaM), MedDRA, WHODrug, performing User Acceptance Testing, and developing scope of work for statistical programming and vendor selection. 10% domestic and international travel required.