BioNTech SE
(Senior) Director Biostatistics(m/w/x)
Full-timeOn-siteSenior
Mainz, München
from USD 198,900 - 298,300 / year
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BIBioNTech SE
Senior Director Biostatistics (Oncology)(m/w/x)
Mainz, München
from USD 198,900 - 305,300 / year
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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
Work Experience
- 15 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- EAST
- NQuery
Benefits
Bonuses & Incentives
- Annual bonus
Competitive Pay
- Equity
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BIBioNTech SE
Senior Director Biostatistics (Oncology)(m/w/x)
Mainz, München
from USD 198,900 - 305,300 / year
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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
Work Experience
- 15 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- EAST
- NQuery
Benefits
Bonuses & Incentives
- Annual bonus
Competitive Pay
- Equity
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
- BioNTech SE
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Manager Statistical Programming(m/w/x)
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