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
BIBioNTech SE
Associate Director Biostatistics(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Statistical lead for oncology/infectious disease clinical trials, ensuring accuracy for regulatory submissions. 8 years of pharma/CRO experience with leadership required. Annual bonus and equity offered.
Anforderungen
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 5 years (8 years for masters) in pharmaceutical industry and/or CRO
- At least 3 years work/leadership experience overseeing statistics staff and representing Biostatistics in matrix/multidisciplinary teams
- Experience in planning, conducting, and analyzing oncology or infectious diseases trials (phase I-IV), including publications
- Experience answering health authority questions (FDA, EMA) and leading statistics on regulatory submissions, including ISE/ISS packages
- Good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
- Good knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
- Very good understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE (a plus)
- Very good analytical skills for complex issue analysis, planning, and communication
- Strong drive for high-quality, timely results, safeguarding ethical standards
- Very good communication skills
- Ability to express complex analysis in clear language
- Excellent command of English (written and spoken)
Aufgaben
- Represent Statistics in cross-functional clinical study teams
- Account for all statistical aspects of projects
- Provide statistical input into clinical development plans
- Contribute to clinical study protocols and reports
- Ensure accuracy of regulatory submission documents and publications
- Collaborate with cross-functional team members
- Perform and verify sample size calculations
- Lead development of statistical analysis plans and TLFs
- Conduct and validate statistical analyses
- Participate in health authority meeting planning
- Develop associated documents and responses
- Oversee outsourced statistical CRO activities
- Ensure high-quality and timely deliverables
- Support departmental strategy development
- Guide Statistical Programmers on SDTM/ADaM and TLFs
- Provide input to database requirements
- Work with Clinical Data Manager to ensure data quality
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- R
- EAST
- NQuery
Benefits
Boni & Prämien
- Annual bonus
Attraktive Vergütung
- Equity
- Competitive remuneration packages
Mentale Gesundheitsförderung
- Wellbeing support
Mitarbeiterrabatte
- Variety of benefits
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
Associate Director Biostatistics(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Statistical lead for oncology/infectious disease clinical trials, ensuring accuracy for regulatory submissions. 8 years of pharma/CRO experience with leadership required. Annual bonus and equity offered.
Anforderungen
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 5 years (8 years for masters) in pharmaceutical industry and/or CRO
- At least 3 years work/leadership experience overseeing statistics staff and representing Biostatistics in matrix/multidisciplinary teams
- Experience in planning, conducting, and analyzing oncology or infectious diseases trials (phase I-IV), including publications
- Experience answering health authority questions (FDA, EMA) and leading statistics on regulatory submissions, including ISE/ISS packages
- Good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
- Good knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
- Very good understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE (a plus)
- Very good analytical skills for complex issue analysis, planning, and communication
- Strong drive for high-quality, timely results, safeguarding ethical standards
- Very good communication skills
- Ability to express complex analysis in clear language
- Excellent command of English (written and spoken)
Aufgaben
- Represent Statistics in cross-functional clinical study teams
- Account for all statistical aspects of projects
- Provide statistical input into clinical development plans
- Contribute to clinical study protocols and reports
- Ensure accuracy of regulatory submission documents and publications
- Collaborate with cross-functional team members
- Perform and verify sample size calculations
- Lead development of statistical analysis plans and TLFs
- Conduct and validate statistical analyses
- Participate in health authority meeting planning
- Develop associated documents and responses
- Oversee outsourced statistical CRO activities
- Ensure high-quality and timely deliverables
- Support departmental strategy development
- Guide Statistical Programmers on SDTM/ADaM and TLFs
- Provide input to database requirements
- Work with Clinical Data Manager to ensure data quality
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- R
- EAST
- NQuery
Benefits
Boni & Prämien
- Annual bonus
Attraktive Vergütung
- Equity
- Competitive remuneration packages
Mentale Gesundheitsförderung
- Wellbeing support
Mitarbeiterrabatte
- Variety of benefits
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.
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
(Senior) Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSeniorMainz, Münchenab USD 198.900 - 298.300 / Jahr - BioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Statistical Expert CMC - Analytical Development(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Manager Statistical Programming(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
Associate Director Translational Sciences (Infectious Diseases)(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz, München