BioNTech SE
(Senior) Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
ab USD 198.900 - 298.300 / Jahr
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BOBoehringer Ingelheim
Senior or Principal Clinical Data Engineer(m/w/x)
Ingelheim am Rhein, Biberach an der Riß
Vollzeit, TeilzeitVor OrtSenior
Nejo KI-Zusammenfassung
Curating clinical trial data for drug development decisions. Several years of clinical data management experience required. Agile team collaboration, product owner experience.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- EDC systems
- CDISC standards
- SAS
- R
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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Praktikum Clinical Data Management (Clinical Data Engineering)(m/w/x)
VollzeitPraktikumnur vor OrtIngelheim am Rhein, Biberachab 900 / Monat
BOBoehringer Ingelheim
Senior or Principal Clinical Data Engineer(m/w/x)
Ingelheim am Rhein, Biberach an der Riß
Vollzeit, TeilzeitVor OrtSenior
Nejo KI-Zusammenfassung
Curating clinical trial data for drug development decisions. Several years of clinical data management experience required. Agile team collaboration, product owner experience.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- EDC systems
- CDISC standards
- SAS
- R
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Boehringer Ingelheim
Branche
Pharmaceuticals
Beschreibung
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
Noch nicht perfekt?
- BioNTech SE
(Senior) Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSeniorMainz, Münchenab USD 198.900 - 298.300 / Jahr - BioNTech SE
Manager Statistical Programming(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
Associate Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSeniorMainz - Fusion Consulting
Senior Data Strategy & Migration Consultant (Pharma)(m/w/x)
Vollzeitnur vor OrtManagementMainz - Boehringer Ingelheim
Praktikum Clinical Data Management (Clinical Data Engineering)(m/w/x)
VollzeitPraktikumnur vor OrtIngelheim am Rhein, Biberachab 900 / Monat