BioNTech SE
Associate Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSenior
Mainz
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BIBioNTech SE
(Senior) Director Biostatistics(m/w/x)
Mainz, München
ab USD 198.900 - 298.300 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading biostatistics for oncology and infectious disease trials, from Phase I-IV. 5+ years leadership experience required. Annual bonus and equity.
Anforderungen
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 10 years (13 years for masters) in pharmaceutical industry and/or CRO
- At least 5 years leadership experience overseeing statistics staff
- Experience in planning, conducting, and analyzing oncology/infectious diseases trials (phase I-IV)
- Experience leading to health authority questions (FDA, EMA) and regulatory submissions
- Very good knowledge of clinical development, study designs, advanced statistical methods, regulatory guidelines (ICH, FDA, EMA)
- Very good knowledge of SAS or R and sample size calculation software (EAST, NQuery)
- Deep understanding of special topics (Diagnostics, Biomarker, PK/PD, PRO, RWE) is a plus
- Excellent analytical skills and ability to analyze complex issues and communicate plans
- Strong drive for high-quality results and timely completion, safeguarding ethical standards
- Excellent 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 as biostatistics lead
- Provide statistical input into clinical development plans
- Contribute to clinical study protocols and reports
- Ensure accuracy in regulatory submission documents and publications
- Collaborate with cross-functional teams
- 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 strategies and cross-functional initiatives
- Develop standards, infrastructures, and processes
- Manage and develop junior staff
- Recruit and retain talent
- Guide Statistical Programmers on SDTM/ADaM and TLFs
- Provide input to database requirements
- Work with Clinical Data Manager to ensure data quality
Berufserfahrung
- 10 - 13 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
Sonstige Vorteile
- Diverse employee base support
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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Associate Director Scientific/Medical Writing(m/w/x)
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BIBioNTech SE
(Senior) Director Biostatistics(m/w/x)
Mainz, München
ab USD 198.900 - 298.300 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading biostatistics for oncology and infectious disease trials, from Phase I-IV. 5+ years leadership experience required. Annual bonus and equity.
Anforderungen
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 10 years (13 years for masters) in pharmaceutical industry and/or CRO
- At least 5 years leadership experience overseeing statistics staff
- Experience in planning, conducting, and analyzing oncology/infectious diseases trials (phase I-IV)
- Experience leading to health authority questions (FDA, EMA) and regulatory submissions
- Very good knowledge of clinical development, study designs, advanced statistical methods, regulatory guidelines (ICH, FDA, EMA)
- Very good knowledge of SAS or R and sample size calculation software (EAST, NQuery)
- Deep understanding of special topics (Diagnostics, Biomarker, PK/PD, PRO, RWE) is a plus
- Excellent analytical skills and ability to analyze complex issues and communicate plans
- Strong drive for high-quality results and timely completion, safeguarding ethical standards
- Excellent 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 as biostatistics lead
- Provide statistical input into clinical development plans
- Contribute to clinical study protocols and reports
- Ensure accuracy in regulatory submission documents and publications
- Collaborate with cross-functional teams
- 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 strategies and cross-functional initiatives
- Develop standards, infrastructures, and processes
- Manage and develop junior staff
- Recruit and retain talent
- Guide Statistical Programmers on SDTM/ADaM and TLFs
- Provide input to database requirements
- Work with Clinical Data Manager to ensure data quality
Berufserfahrung
- 10 - 13 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
Sonstige Vorteile
- Diverse employee base support
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
Associate Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Manager Statistical Programming(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Statistical Expert CMC - Analytical Development(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Vollzeitnur vor OrtSeniorMainz