BioNTech SE
Associate Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSenior
Mainz
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BIBioNTech SE
Manager Statistical Programming(m/w/x)
Mainz
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Statistical programming for clinical trials in oncology and infectious diseases. Advanced degree and 5+ years in pharma/CRO required. Collaboration with global programming standard library development.
Anforderungen
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline
- Advanced degree preferred
- 5+ years experience in pharmaceutical industry, CRO or clinical research setting
- 3+ years experience with advanced degree in pharmaceutical industry, CRO or clinical research setting
- Strong competence in SAS/Base, Macro, STAT, GRAPH, SQL
- Good understanding of FDA, EMA, ICH, and global regulations
- Solid knowledge of industry standards for clinical study data and reporting
- Solid knowledge of industry standards for reporting on clinical trials
- Solid experience of industry standards for clinical study data and reporting
- Solid experience of industry standards for reporting on clinical trials
- Solid knowledge and experience of CDISC standards
- Oncology or infectious disease therapeutic areas experience preferred
- Submission experience preferred
- Project management experience
- Detail-oriented skills
- Strong organizational skills
- Strong communication skills
- Ability to work in fast-paced environment
- Ability to work in dynamic environment
- Ability to work in team environment
- Strong analytical skills
- Strong problem-solving skills
Aufgaben
- Collaborate with Clinical Development team or CRO to meet project deliverables and timelines
- Perform or oversee production and validation of programming deliverables
- Anticipate resource needs and ensure long-term resource allocation
- Ensure quality control on all process and technical activities
- Participate in developing a global programming standard library
- Develop tools for efficient production and verification of derived datasets
- Provide functional expertise in developing BioNTech’s clinical data repository
- Collaborate with Biostatistics to develop statistical applications
- Provide programming support for regulatory submissions
- Develop data submission packages and define.xml files
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS/Base
- SAS Macro
- SAS STAT
- SAS GRAPH
- SQL
- CDISC standards
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE 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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BIBioNTech SE
Manager Statistical Programming(m/w/x)
Mainz
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Statistical programming for clinical trials in oncology and infectious diseases. Advanced degree and 5+ years in pharma/CRO required. Collaboration with global programming standard library development.
Anforderungen
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline
- Advanced degree preferred
- 5+ years experience in pharmaceutical industry, CRO or clinical research setting
- 3+ years experience with advanced degree in pharmaceutical industry, CRO or clinical research setting
- Strong competence in SAS/Base, Macro, STAT, GRAPH, SQL
- Good understanding of FDA, EMA, ICH, and global regulations
- Solid knowledge of industry standards for clinical study data and reporting
- Solid knowledge of industry standards for reporting on clinical trials
- Solid experience of industry standards for clinical study data and reporting
- Solid experience of industry standards for reporting on clinical trials
- Solid knowledge and experience of CDISC standards
- Oncology or infectious disease therapeutic areas experience preferred
- Submission experience preferred
- Project management experience
- Detail-oriented skills
- Strong organizational skills
- Strong communication skills
- Ability to work in fast-paced environment
- Ability to work in dynamic environment
- Ability to work in team environment
- Strong analytical skills
- Strong problem-solving skills
Aufgaben
- Collaborate with Clinical Development team or CRO to meet project deliverables and timelines
- Perform or oversee production and validation of programming deliverables
- Anticipate resource needs and ensure long-term resource allocation
- Ensure quality control on all process and technical activities
- Participate in developing a global programming standard library
- Develop tools for efficient production and verification of derived datasets
- Provide functional expertise in developing BioNTech’s clinical data repository
- Collaborate with Biostatistics to develop statistical applications
- Provide programming support for regulatory submissions
- Develop data submission packages and define.xml files
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS/Base
- SAS Macro
- SAS STAT
- SAS GRAPH
- SQL
- CDISC standards
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE 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
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Noch nicht perfekt?
- BioNTech SE
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VollzeitPraktikumnur vor OrtBiberach, Ingelheim am Rhein - Boehringer Ingelheim
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Vollzeitnur vor OrtSeniorMainz, München