Boehringer Ingelheim
Principal Clinical Data Scientist - Statistician
Boehringer Ingelheim, Ridgefield, Connecticut, us, 06877
Description
Supports the clinical drug research and development process by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to clinical projects like actual trial data, registries and real-world data bases. In particular this includes the provision of analytics tools, outputs and inference as necessary for the specific use case. May act as a BDS product owner up to substance/asset level.Represent BDS at a substance/asset level regarding data science related aspects.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
Lead and oversee designing, transforming, analyzing and reporting complex phase I-IV clinical trials or projects with established BI experience and supporting complex international R&D projects.
Lead and oversee for designing, transforming, analyzing and reporting of other data from research and development like registries and real-world data bases with respect to a specific use case or project/asset.
Keep abreast of data science within and outside BI. Turn derived insights into new data science approaches relevant for clinical development, registration, and marketing of drugs.
Present compelling validated stories regarding complex data science aspects to BDS colleagues and other professionals within and outside of BI.
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 customer and external providers on data science related tasks.
Participate in cross-functional BI internal working-groups or lead cross-functional human pharma internal working-groups and drive/plan relevant data science aspects. Participate in external working groups.
If applicable, supports the clinical drug development process as a BDS Product Owner up to the level of substance/assets.
Ensures cross-functional and team-based working within BDS and with other units at BI. Fulfils tasks of other functions as needed and possible. Contributes to cross-functional- and team-based thinking.
Support fostering innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models.
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 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.
Working experience might be partially compensated by broad and deep topic-specific knowledge.
Broad knowledge and advanced experience in software languages relevant for business needs.
Broad knowledge and advanced experience in understanding of clinical trial development process required.
Advanced project lead experience required.
Understanding and applying key of principles of data science.
In-depth understanding of advanced statistical concepts related to Data Science.
Demonstrated broad knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex clinical trials, in projects with established BI experience or data from other sources in clinical research and development.
Thorough knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information.
Advanced working knowledge of broad variety of aspects of relevant software languages.
Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
Ability to lead and facilitate meetings.
Ability to develop and deliver training related to data science topics.
Evidence of strong teamwork, also in global and remote context.
Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g. CROs, experts, management).
Ability to pro-actively identify issues and solutions and to interact with internal and external bodies on routine data science issues.
Language skills: English: fluent (Read/Write/Speak).
Know, 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).
Compensation
This position offers a base salary typically between $135,000 and $232,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (https://www.boehringer-ingelheim.us/sites/us/files/files/2021-bi-benefits-overview.pdf)
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.
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.
Supports the clinical drug research and development process by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to clinical projects like actual trial data, registries and real-world data bases. In particular this includes the provision of analytics tools, outputs and inference as necessary for the specific use case. May act as a BDS product owner up to substance/asset level.Represent BDS at a substance/asset level regarding data science related aspects.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
Lead and oversee designing, transforming, analyzing and reporting complex phase I-IV clinical trials or projects with established BI experience and supporting complex international R&D projects.
Lead and oversee for designing, transforming, analyzing and reporting of other data from research and development like registries and real-world data bases with respect to a specific use case or project/asset.
Keep abreast of data science within and outside BI. Turn derived insights into new data science approaches relevant for clinical development, registration, and marketing of drugs.
Present compelling validated stories regarding complex data science aspects to BDS colleagues and other professionals within and outside of BI.
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 customer and external providers on data science related tasks.
Participate in cross-functional BI internal working-groups or lead cross-functional human pharma internal working-groups and drive/plan relevant data science aspects. Participate in external working groups.
If applicable, supports the clinical drug development process as a BDS Product Owner up to the level of substance/assets.
Ensures cross-functional and team-based working within BDS and with other units at BI. Fulfils tasks of other functions as needed and possible. Contributes to cross-functional- and team-based thinking.
Support fostering innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models.
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 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.
Working experience might be partially compensated by broad and deep topic-specific knowledge.
Broad knowledge and advanced experience in software languages relevant for business needs.
Broad knowledge and advanced experience in understanding of clinical trial development process required.
Advanced project lead experience required.
Understanding and applying key of principles of data science.
In-depth understanding of advanced statistical concepts related to Data Science.
Demonstrated broad knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex clinical trials, in projects with established BI experience or data from other sources in clinical research and development.
Thorough knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information.
Advanced working knowledge of broad variety of aspects of relevant software languages.
Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
Ability to lead and facilitate meetings.
Ability to develop and deliver training related to data science topics.
Evidence of strong teamwork, also in global and remote context.
Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g. CROs, experts, management).
Ability to pro-actively identify issues and solutions and to interact with internal and external bodies on routine data science issues.
Language skills: English: fluent (Read/Write/Speak).
Know, 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).
Compensation
This position offers a base salary typically between $135,000 and $232,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (https://www.boehringer-ingelheim.us/sites/us/files/files/2021-bi-benefits-overview.pdf)
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.
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.