AD, Principal Clinical Data Engineer

BoehringerPRD•Brampton, ON

1d•$140,000 - $222,000

About The Position

This role serves as a key partner in leveraging data for clinical trials. Responsibilities include data collection, curation, review, and delivery, as well as data standardization and process definition, testing, and training. The position involves translating scientific requirements into technical specifications, ensuring data quality and integrity through checks and anomaly detection, with a focus on SDTM compliance for regulatory submissions. The role requires advanced expertise in CDISC standards, particularly SDTM, including the design, implementation, review, and governance of mapping specifications, datasets, and transformations. The Principal Clinical Data Engineer interprets scientific and clinical requirements to create technical specifications for new substances, indications, or marketing claims. As an employee of Boehringer Ingelheim, this role contributes to the discovery, development, and delivery of products, with opportunities for international collaboration and visibility. The company supports employees through a healthy working environment, meaningful work, mobility, networking, and work-life balance, complemented by competitive compensation and benefit programs.

Requirements

Bachelor’s degree from an accredited institution, in Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred, with many (greater than or equal to seven (>/= 7)) years of professional experience; Or Master’s degree (e.g. MBA, MSc) from an accredited institution, in Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred, with greater than or equal to three (3) years of professional experience.
Initial experience within the pharmaceutical industry, CROs or academic sites.
Leadership experience required.
Broad knowledge and advanced experience in understanding of clinical trial development process required.
In-depth knowledge and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods, requirements
Thorough knowledge/experience in design of clinical trials, basic medical terminology and on processing clinical trial information.
Demonstrated ability to build/test, curate, oversee and interpret data in complex clinical trial and in projects with established BI experience.
Intellectual curiosity to find new and unusual ways solving data collection / curation / standardization / process definition, testing and training issues.
Excellent organizational skills, problem solving abilities, negotiation skills, time management skills and initiative required.
Strong communication skills: Confident and persuasive communicator to ensure that the message is clear and well understood.
Ability to work collaboratively on multi-disciplinary project teams and proactively manage relationships with external vendors required.
Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
Ability to lead and facilitate meetings required.
Ability to develop and deliver (technical) training required.
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, data standardization, and
BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan)

Responsibilities

Accountable/Responsible to interpret requirements to translate and document them into project/TA level technical specifications.
Provision clinical project/ TA level data to business consumers.
Facilitate requirements gathering from consumers and develop global solutions to meet immediate and long-term needs of the business.
Monitor and maintain ongoing project/ TA level operations of clinical data environments and respond to project/TA issues.
Leads and oversees all CDE tasks performed by an external partner.
Oversees CRO capacities/budget for outsourced trial/project tasks.
Develop/test different ways to constantly improve data reliability, integrity and quality.
Ensures real-time inspection readiness of all data collection, data review/data delivery (DBL) deliverables for a trial/project and participates in regulatory agency and BI internal audits as necessary.
Collaborate with/influence members of the development team within BDS and with neighboring colleagues at BI on the project/product goals.
Contributes to cross-functional- and team-based thinking.
Keep abreast of data science and in particular new data collection/curation/standardization/digital tech solutions and innovative processes/tools within and outside BI.
Turn derived insights into new CDE approaches relevant for clinical development, registration, and marketing of drugs.
Conduct and support data collection/curation/standards process & tool trainings for Clinical Data Engineers.
Participate in or Lead cross-functional BI internal process development teams and drive/plan relevant CDE (data collection/curation/standardization) aspects.
Participate in external working groups.