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
Director Statistical Programming - Infectious Diseases(m/w/x)
Mainz, München
from USD 168,000 - 268,700 / year
Full-timeOn-siteSenior
Nejo AI Summary
Leading statistical programming for infectious disease clinical trials, managing SAS deliverables and regulatory compliance. 15+ years of pharmaceutical programming experience required. Annual bonus and equity offered.
Requirements
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
- 15+ years (10+ for advanced degree) experience in pharmaceutical industry, CRO, or clinical research setting, focus on infectious diseases
- Excellent knowledge of SAS programming (Base, macro, STAT, GRAPH, SQL)
- Solid understanding of FDA, EMA, ICH, and global regulations/guidelines
- Solid understanding of industry standards for clinical study data and reporting (CDISC)
- Solid understanding of drug development process (early- to late-stage)
- Expertise in requirements and technology for electronic submissions
- Strong project and portfolio management skills
- Strong interpersonal and communication skills (written and oral)
- Ability to lead cross-functional teams and influence stakeholders
- Ability to manage multiple programs in fast-paced environment
- Strong analytical and problem-solving skills, focus on innovation/automation
Tasks
- Lead statistical programming for Infectious Diseases therapeutic area
- Implement comprehensive statistical programming strategy
- Ensure alignment with corporate and regulatory requirements
- Oversee statistical programming deliverables for multiple programs
- Manage analysis datasets, tables, listings, and figures
- Ensure programming strategies meet compound and indication needs
- Lead programming for global regulatory submissions
- Ensure compliance with eCTD requirements
- Develop and oversee data standards and automation tools
- Create, review, and validate SAS/R programs for data analysis
- Collaborate cross-functionally with various stakeholders
- Represent statistical programming in clinical study teams
- Guide internal and external project leads
- Champion advanced analytics and new technologies
- Enhance programming efficiency and scientific insight
Work Experience
- 10 - 15 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
Tools & Technologies
- SAS
- Base SAS
- SAS macro
- SAS STAT
- SAS GRAPH
- SAS SQL
- CDISC
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
Director Statistical Programming - Infectious Diseases(m/w/x)
Mainz, München
from USD 168,000 - 268,700 / year
Full-timeOn-siteSenior
Nejo AI Summary
Leading statistical programming for infectious disease clinical trials, managing SAS deliverables and regulatory compliance. 15+ years of pharmaceutical programming experience required. Annual bonus and equity offered.
Requirements
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
- 15+ years (10+ for advanced degree) experience in pharmaceutical industry, CRO, or clinical research setting, focus on infectious diseases
- Excellent knowledge of SAS programming (Base, macro, STAT, GRAPH, SQL)
- Solid understanding of FDA, EMA, ICH, and global regulations/guidelines
- Solid understanding of industry standards for clinical study data and reporting (CDISC)
- Solid understanding of drug development process (early- to late-stage)
- Expertise in requirements and technology for electronic submissions
- Strong project and portfolio management skills
- Strong interpersonal and communication skills (written and oral)
- Ability to lead cross-functional teams and influence stakeholders
- Ability to manage multiple programs in fast-paced environment
- Strong analytical and problem-solving skills, focus on innovation/automation
Tasks
- Lead statistical programming for Infectious Diseases therapeutic area
- Implement comprehensive statistical programming strategy
- Ensure alignment with corporate and regulatory requirements
- Oversee statistical programming deliverables for multiple programs
- Manage analysis datasets, tables, listings, and figures
- Ensure programming strategies meet compound and indication needs
- Lead programming for global regulatory submissions
- Ensure compliance with eCTD requirements
- Develop and oversee data standards and automation tools
- Create, review, and validate SAS/R programs for data analysis
- Collaborate cross-functionally with various stakeholders
- Represent statistical programming in clinical study teams
- Guide internal and external project leads
- Champion advanced analytics and new technologies
- Enhance programming efficiency and scientific insight
Work Experience
- 10 - 15 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
Tools & Technologies
- SAS
- Base SAS
- SAS macro
- SAS STAT
- SAS GRAPH
- SAS SQL
- CDISC
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?
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