BioNTech SE
Associate Director Biostatistics(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Associate Director Statistical Programming (Oncology)(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Leading statistical programming for oncology clinical trials, managing internal teams and external vendors. Oncology experience required. Annual bonus and equity offered.
Requirements
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
- 10+ years (5+ years for advanced degree) experience in pharmaceutical industry, CRO, or clinical research setting
- Excellent knowledge of statistical programming (SAS/Base, Macro, STAT, GRAPH, SQL)
- Solid understanding of FDA, EMA, ICH, and global regulations/guidelines
- Oncology experience required
- Project management experience required
- Strong interpersonal skills
- Exceptional written and oral communication skills
- Ability to work in fast-paced, dynamic team environment
Tasks
- Implement global statistical programming strategy
- Lead statistical programming deliverables
- Ensure alignment with protocols and SAPs
- Manage internal programmers and external vendors
- Maintain quality, consistency, and compliance
- Review and validate SAS/R programs
- Troubleshoot data transformation and analysis
- Ensure accuracy of efficacy and safety outputs
- Perform quality control and resolve discrepancies
- Serve as primary programming point of contact
- Interpret analysis requirements with Biostatistics
- Address data issues with Clinical Operations
- Prepare submission-ready materials with Regulatory Affairs
- Manage relationships with outsourced partners
- Negotiate scope and oversee timelines
- Conduct quality audits
- Anticipate and monitor resource needs
- Balance workload across studies
- Develop standardized macros and tools
- Implement efficient workflows
- Train junior programmers and CRO staff
- Provide regulatory submission support
- Develop data submission packages
- Create define.xml files
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS/Base
- SAS Macro
- SAS STAT
- SAS GRAPH
- SQL
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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BIBioNTech SE
Associate Director Statistical Programming (Oncology)(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Leading statistical programming for oncology clinical trials, managing internal teams and external vendors. Oncology experience required. Annual bonus and equity offered.
Requirements
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
- 10+ years (5+ years for advanced degree) experience in pharmaceutical industry, CRO, or clinical research setting
- Excellent knowledge of statistical programming (SAS/Base, Macro, STAT, GRAPH, SQL)
- Solid understanding of FDA, EMA, ICH, and global regulations/guidelines
- Oncology experience required
- Project management experience required
- Strong interpersonal skills
- Exceptional written and oral communication skills
- Ability to work in fast-paced, dynamic team environment
Tasks
- Implement global statistical programming strategy
- Lead statistical programming deliverables
- Ensure alignment with protocols and SAPs
- Manage internal programmers and external vendors
- Maintain quality, consistency, and compliance
- Review and validate SAS/R programs
- Troubleshoot data transformation and analysis
- Ensure accuracy of efficacy and safety outputs
- Perform quality control and resolve discrepancies
- Serve as primary programming point of contact
- Interpret analysis requirements with Biostatistics
- Address data issues with Clinical Operations
- Prepare submission-ready materials with Regulatory Affairs
- Manage relationships with outsourced partners
- Negotiate scope and oversee timelines
- Conduct quality audits
- Anticipate and monitor resource needs
- Balance workload across studies
- Develop standardized macros and tools
- Implement efficient workflows
- Train junior programmers and CRO staff
- Provide regulatory submission support
- Develop data submission packages
- Create define.xml files
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS/Base
- SAS Macro
- SAS STAT
- SAS GRAPH
- SQL
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.
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
Associate Director Biostatistics(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
(Senior) Director Biostatistics(m/w/x)
Full-timeOn-siteSeniorMainz, Münchenfrom USD 198,900 - 298,300 / year - BioNTech SE
Manager Statistical Programming(m/w/x)
Full-timeOn-siteExperiencedMainz - BioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Associate Director Audit Management(m/w/x)
Full-timeOn-siteSeniorMainz, München