BioNTech SE
(Senior) Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
ab USD 198.900 - 298.300 / Jahr
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BIBioNTech SE
Senior Director Biostatistics (Oncology)(m/w/x)
Mainz, München
ab USD 198.900 - 305.300 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Statistical lead for oncology and infectious disease trials, guiding clinical development plans and regulatory submissions. 15+ years pharma experience with leadership in health authority responses required. Annual bonus and equity.
Anforderungen
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 15 years (18 for masters) in pharmaceutical industry/CRO
- At least 10 years work/leadership experience overseeing statistics staff and representing Biostatistics in matrix/multidisciplinary team
- Experience planning, conducting, analyzing oncology/infectious diseases trials (phase I-IV), including publications
- Experience leading health authority question responses (FDA, EMA) and statistics on regulatory submissions, including ISE/ISS packages
- Excellent knowledge/experience clinical development, study designs, advanced statistical methods (adaptive design/Bayesian a plus), regulatory guidelines (ICH, FDA, EMA)
- Excellent knowledge statistical software (SAS or R) and sample size calculation software (EAST and/or NQuery)
- Very deep understanding special topics (Diagnostics, Biomarker, PK/PD, PRO, RWE) is a plus
- Outstanding analytical skills for complex issues, developing plans, programs, recommendations, risk mitigation, and communicating them
- Strong drive for high-quality, timely results, 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 in assigned programs
- Serve as biostatistics lead in cross-functional process development
- Provide statistical guidance in clinical development plans
- Contribute to clinical study protocols and reports
- Ensure accuracy in regulatory submission documents and publications
- Collaborate with cross-functional teams from various disciplines
- Perform and verify sample size calculations
- Develop statistical analysis plans and TLFs
- Conduct statistical analyses and validate results
- Participate in health authority meeting planning
- Develop and prepare associated documents and responses
- Oversee outsourced statistical CRO activities and deliverables
- Support departmental strategies and cross-functional initiatives
- Assist GBS Lead in strategy and operations
- Manage staff recruitment, development, and retention
- Guide Statistical Programmers on SDTM/ADaM and TLFs
- Provide input to database requirements
- Work with Clinical Data Manager to ensure data quality
Berufserfahrung
- 15 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- R
- EAST
- NQuery
Benefits
Boni & Prämien
- Annual bonus
Attraktive Vergütung
- Equity
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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Senior Director Biostatistics (Oncology)(m/w/x)
Mainz, München
ab USD 198.900 - 305.300 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Statistical lead for oncology and infectious disease trials, guiding clinical development plans and regulatory submissions. 15+ years pharma experience with leadership in health authority responses required. Annual bonus and equity.
Anforderungen
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 15 years (18 for masters) in pharmaceutical industry/CRO
- At least 10 years work/leadership experience overseeing statistics staff and representing Biostatistics in matrix/multidisciplinary team
- Experience planning, conducting, analyzing oncology/infectious diseases trials (phase I-IV), including publications
- Experience leading health authority question responses (FDA, EMA) and statistics on regulatory submissions, including ISE/ISS packages
- Excellent knowledge/experience clinical development, study designs, advanced statistical methods (adaptive design/Bayesian a plus), regulatory guidelines (ICH, FDA, EMA)
- Excellent knowledge statistical software (SAS or R) and sample size calculation software (EAST and/or NQuery)
- Very deep understanding special topics (Diagnostics, Biomarker, PK/PD, PRO, RWE) is a plus
- Outstanding analytical skills for complex issues, developing plans, programs, recommendations, risk mitigation, and communicating them
- Strong drive for high-quality, timely results, 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 in assigned programs
- Serve as biostatistics lead in cross-functional process development
- Provide statistical guidance in clinical development plans
- Contribute to clinical study protocols and reports
- Ensure accuracy in regulatory submission documents and publications
- Collaborate with cross-functional teams from various disciplines
- Perform and verify sample size calculations
- Develop statistical analysis plans and TLFs
- Conduct statistical analyses and validate results
- Participate in health authority meeting planning
- Develop and prepare associated documents and responses
- Oversee outsourced statistical CRO activities and deliverables
- Support departmental strategies and cross-functional initiatives
- Assist GBS Lead in strategy and operations
- Manage staff recruitment, development, and retention
- Guide Statistical Programmers on SDTM/ADaM and TLFs
- Provide input to database requirements
- Work with Clinical Data Manager to ensure data quality
Berufserfahrung
- 15 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- R
- EAST
- NQuery
Benefits
Boni & Prämien
- Annual bonus
Attraktive Vergütung
- Equity
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
(Senior) Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSeniorMainz, Münchenab USD 198.900 - 298.300 / Jahr - BioNTech SE
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Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Director Statistical Programming - Infectious Diseases(m/w/x)
Vollzeitnur vor OrtSeniorMainz, Münchenab USD 168.000 - 268.700 / Jahr - BioNTech SE
Manager Statistical Programming(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Vollzeitnur vor OrtSeniorMainz