Principal Clinical Data Scientist

Scorpion Therapeutics; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

A leading pharmaceutical company is seeking a Principal Clinical Data Scientist to lead the design and analysis of complex clinical studies. The role requires extensive experience in clinical data analysis, particularly in the CNS Therapeutic Area, alongside strong SAS programming skills. This position offers the flexibility of telecommuting within the U.S. and involves collaboration across various teams to ensure compliance with international regulations.

Qualifications

• Master's or Bachelor's degree in relevant field.
• 6-7 years of relevant experience in Clinical Data Science.
• Experience in leading FDA submission activities.

Responsibilities

• Lead design and analysis of complex clinical studies.
• Oversee data transformation and ensure GxP compliance.
• Guide cross-functional teams on data science tasks.

Skills

SAS macro language

SAS SQL

SAS Stat

Clinical Data Standards

Statistical programming

Education

Master's degree in Statistics

Bachelor’s degree in Statistics

Tools

Clinical Data Interchange Standards Consortium

Medical Dictionary for Regulatory Activities

WHODrug dictionary

Job description

If you're aiming for a job like this, you need an edge.

JobsAI gives you that edge—by helping you upgrade your resume, analyze hiring managers’ LinkedIn profiles, and prepare with a built-in interview coach.

This is the smarter, faster way to compete in today’s job market.

Check out JobsAI

Description

Principal Clinical Data Scientist at Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT (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.

Our Company

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths – and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after – as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com