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
Associate Director Biostatistics(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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
Work Experience
- 5 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
Corporate Discounts
- Variety of benefits
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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Full-timeOn-siteExperiencedMainz, München
BIBioNTech SE
Associate Director Biostatistics(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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
Work Experience
- 5 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
Corporate Discounts
- Variety of benefits
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
(Senior) Director Biostatistics(m/w/x)
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Associate Director Scientific/Medical Writing(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Statistical Expert CMC - Analytical Development(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Manager Statistical Programming(m/w/x)
Full-timeOn-siteExperiencedMainz - BioNTech SE
Associate Director Translational Sciences (Infectious Diseases)(m/w/x)
Full-timeOn-siteExperiencedMainz, München