BioNTech SE
Associate Director Biostatistics(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
(Senior) Director Biostatistics(m/w/x)
Mainz, München
from USD 198,900 - 298,300 / year
Full-timeOn-siteSenior
Nejo AI Summary
Leading biostatistics for oncology and infectious disease trials, from Phase I-IV. 5+ years leadership experience required. Annual bonus and equity.
Requirements
- 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)
Tasks
- 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
Work Experience
- 10 - 13 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- EAST
- NQuery
Benefits
Bonuses & Incentives
- Annual bonus
Competitive Pay
- Equity
- Competitive remuneration packages
Mental Health Support
- Wellbeing support
Other Benefits
- Diverse employee base support
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(m/w/x)
Mainz, München
from USD 198,900 - 298,300 / year
Full-timeOn-siteSenior
Nejo AI Summary
Leading biostatistics for oncology and infectious disease trials, from Phase I-IV. 5+ years leadership experience required. Annual bonus and equity.
Requirements
- 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)
Tasks
- 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
Work Experience
- 10 - 13 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- EAST
- NQuery
Benefits
Bonuses & Incentives
- Annual bonus
Competitive Pay
- Equity
- Competitive remuneration packages
Mental Health Support
- Wellbeing support
Other Benefits
- Diverse employee base support
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.
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
Associate Director Biostatistics(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Manager Statistical Programming(m/w/x)
Full-timeOn-siteExperiencedMainz - BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Statistical Expert CMC - Analytical Development(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Full-timeOn-siteSeniorMainz