Job Location: United States
Supports the clinical drug research and development process by providing strategic statistical programming planning and execution, including data transformation, data analysis and data reporting.
Tasks & Responsibilities:
Senior Clinical Data Scientist with focus on Statistical Programming
- Provide comprehensive statistical programming support to clinical trials and projects.
- Ensure quality of BDS deliverables by consistently applying analysis and reporting standard.
- Ensure compliance with company and department SOP’s, FDA/ICH/GCP regulations and CDISC standards.
- Develop robust programming specifications for internal and external programming work
- Independently develop, troubleshoot, and maintain programs and utilities to support the creation and validation of datasets and outputs
- Support/guide other colleagues, internal and external customer, and external providers on data science related tasks
- Support the development and implementation of innovative strategies and technologies for data science within and outside of BI
- Participate in cross-functional human pharma internal working-groups or lead cross-functional BDS internal working-groups and drive/plan relevant data science aspects.
- Collaborate closely with scientists and experts from various disciplines in clinical development.
- Enhance business knowledge and scientific expertise in a global environment.
- Exchange expertise in data science community.
Principal Clinical Data Scientist with focus on Statistical Programming
- In addition, lead and oversee statistical programming in complex phase I-IV clinical trials or projects.
Requirements:
- Bachelor of Science (BSc) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.) with a minimum of five (5) years of data science experience; Or
- Master of Science (MSc) from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.) with a minimum of three (3) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions; Or
- Doctoral Degree (PhD) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.
- Advanced knowledge and hands-on experience in relevant software languages in recent years, in particular SAS. Additional R programming skills are of advantage
- Sound knowledge of CDISC standards, design of clinical trials or clinical experiments, basic medical terminology and processing clinical trial information
- Experience in clinical trial and drug development
- Experience in working in/with agile teams and/or as a product owner is a plus
- Ability to pro-actively identify issues and solutions, interact with internal and external team members on routine clinical data science issues
- Interpersonal skills. Interact effectively with people, internally and externally (e.g., CROs, experts, management) as well as evidence of strong teamwork, also in global and remote context.
- Oral and written communication skills to interact in interdisciplinary teams as well as the ability to explain, visualize and communicate complex data science aspects
- Fluency in written and spoken English
Additional requirements for a Principal Position:
- Bachelor of Science (BSc) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.), with a minimum seven (7) years of data science experience; Or
- Master of Science (MSc) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.), with six (6) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions; Or
- Doctoral Degree (PhD) from an accredited institution in Statistics, Mathematics, Computer Science, or related field (Psychology, Data Science, Finance, etc.), with three (3) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions.
- Broad knowledge and advanced experience in understanding of clinical trial and drug development processes
- Comprehensive knowledge of CDISC standards
- Advanced project lead experience
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
- This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. 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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Job – Medicine / Regulatory Affairs
Primary Location – Americas-United States
Other Locations – Americas-US-CT-Ridgefield
Organization – US-BI Pharma/BI USA
Schedule – Full-time
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