BioNTech SE
(Senior) Director Biostatistics(m/w/x)
Full-timeOn-siteSenior
Mainz, München
from USD 198,900 - 298,300 / year
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BOBoehringer Ingelheim
Senior or Principal Clinical Data Engineer(m/w/x)
Ingelheim am Rhein, Biberach an der Riß
Full-time, Part-timeOn-siteSenior
Nejo AI Summary
Curating clinical trial data for drug development decisions. Several years of clinical data management experience required. Agile team collaboration, product owner experience.
Requirements
- Bachelor or Master's degree in Life Sciences, Computer Science, Software/Computer Engineering, or related fields
- Several years of experience in clinical development, especially Clinical Data Management
- High-qualified/multifaceted professional qualifications with relevant professional experience
- Experience in working in agile teams and/or as a product owner
- Understanding of dependencies among interfaces
- Knowledge of standardization methods and requirements
- Knowledge and experience with Data Collection Tools (EDC systems)
- Knowledge and experience with Data Review Tools
- Understanding of CDISC standards (CDASH, SDTM, etc.)
- Technical expertise and/or programming skills
- Strong organizational skills
- Problem-solving abilities
- Time management skills
- Initiative-taking
- Excellent communication skills
- Fluency in English, spoken and written
- Advanced experience in leading complex projects
- Experience within cross-functional or global environments
- Demonstrated expertise in late-phase clinical development
- Experience with regulatory submission processes
- Experience with interactions with health authorities
- Strong proficiency and hands-on experience with SAS
- Strong proficiency and hands-on experience with R
- Experience working in or with agile teams
- Experience serving as a Product Owner
Tasks
- Cultivate the power of data through collection, curation, review, and standardization
- Ensure delivery of high-quality clinical trial data for informed decision-making
- Act as key liaison for data management activities in late-phase trials
- Collaborate with internal and external partners regularly
- Review clinical trial protocols to identify data capture requirements
- Define eCRFs and clinical trial databases, including UAT and edit check specifications
- Oversee creation and maintenance of essential TMF documentation
- Ensure data integrity by creating and executing data quality checks
- Provide sponsor oversight of CROs or external data providers
- Collaborate with trial teams for timely database closure and lock
- Integrate and reconcile external data from vendors or internal departments
- Ensure SDTM-compliant data delivery and address Pinnacle 21 Enterprise outputs
- Present and train at CRA/Investigator meetings
- Onboard new colleagues and conduct trainings within the Clinical Data Engineering community
- Ensure compliance with ICH GCP guidelines and global regulatory requirements
- Participate in regulatory agency and internal audits
- Lead complex technical concepts and shape overarching data strategies
- Identify opportunities to improve and optimize data processes
- Mentor and support the development of Clinical Data Engineers
- Drive digital innovation initiatives across organizational boundaries
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- EDC systems
- CDISC standards
- SAS
- R
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BOBoehringer Ingelheim
Senior or Principal Clinical Data Engineer(m/w/x)
Ingelheim am Rhein, Biberach an der Riß
Full-time, Part-timeOn-siteSenior
Nejo AI Summary
Curating clinical trial data for drug development decisions. Several years of clinical data management experience required. Agile team collaboration, product owner experience.
Requirements
- Bachelor or Master's degree in Life Sciences, Computer Science, Software/Computer Engineering, or related fields
- Several years of experience in clinical development, especially Clinical Data Management
- High-qualified/multifaceted professional qualifications with relevant professional experience
- Experience in working in agile teams and/or as a product owner
- Understanding of dependencies among interfaces
- Knowledge of standardization methods and requirements
- Knowledge and experience with Data Collection Tools (EDC systems)
- Knowledge and experience with Data Review Tools
- Understanding of CDISC standards (CDASH, SDTM, etc.)
- Technical expertise and/or programming skills
- Strong organizational skills
- Problem-solving abilities
- Time management skills
- Initiative-taking
- Excellent communication skills
- Fluency in English, spoken and written
- Advanced experience in leading complex projects
- Experience within cross-functional or global environments
- Demonstrated expertise in late-phase clinical development
- Experience with regulatory submission processes
- Experience with interactions with health authorities
- Strong proficiency and hands-on experience with SAS
- Strong proficiency and hands-on experience with R
- Experience working in or with agile teams
- Experience serving as a Product Owner
Tasks
- Cultivate the power of data through collection, curation, review, and standardization
- Ensure delivery of high-quality clinical trial data for informed decision-making
- Act as key liaison for data management activities in late-phase trials
- Collaborate with internal and external partners regularly
- Review clinical trial protocols to identify data capture requirements
- Define eCRFs and clinical trial databases, including UAT and edit check specifications
- Oversee creation and maintenance of essential TMF documentation
- Ensure data integrity by creating and executing data quality checks
- Provide sponsor oversight of CROs or external data providers
- Collaborate with trial teams for timely database closure and lock
- Integrate and reconcile external data from vendors or internal departments
- Ensure SDTM-compliant data delivery and address Pinnacle 21 Enterprise outputs
- Present and train at CRA/Investigator meetings
- Onboard new colleagues and conduct trainings within the Clinical Data Engineering community
- Ensure compliance with ICH GCP guidelines and global regulatory requirements
- Participate in regulatory agency and internal audits
- Lead complex technical concepts and shape overarching data strategies
- Identify opportunities to improve and optimize data processes
- Mentor and support the development of Clinical Data Engineers
- Drive digital innovation initiatives across organizational boundaries
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- EDC systems
- CDISC standards
- SAS
- R
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Boehringer Ingelheim
Industry
Pharmaceuticals
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
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