BioNTech SE
Associate Director Biostatistics(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Manager Statistical Programming(m/w/x)
Mainz
Full-timeOn-siteExperienced
Nejo AI Summary
Statistical programming for clinical trials in oncology and infectious diseases. Advanced degree and 5+ years in pharma/CRO required. Collaboration with global programming standard library development.
Requirements
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline
- Advanced degree preferred
- 5+ years experience in pharmaceutical industry, CRO or clinical research setting
- 3+ years experience with advanced degree in pharmaceutical industry, CRO or clinical research setting
- Strong competence in SAS/Base, Macro, STAT, GRAPH, SQL
- Good understanding of FDA, EMA, ICH, and global regulations
- Solid knowledge of industry standards for clinical study data and reporting
- Solid knowledge of industry standards for reporting on clinical trials
- Solid experience of industry standards for clinical study data and reporting
- Solid experience of industry standards for reporting on clinical trials
- Solid knowledge and experience of CDISC standards
- Oncology or infectious disease therapeutic areas experience preferred
- Submission experience preferred
- Project management experience
- Detail-oriented skills
- Strong organizational skills
- Strong communication skills
- Ability to work in fast-paced environment
- Ability to work in dynamic environment
- Ability to work in team environment
- Strong analytical skills
- Strong problem-solving skills
Tasks
- Collaborate with Clinical Development team or CRO to meet project deliverables and timelines
- Perform or oversee production and validation of programming deliverables
- Anticipate resource needs and ensure long-term resource allocation
- Ensure quality control on all process and technical activities
- Participate in developing a global programming standard library
- Develop tools for efficient production and verification of derived datasets
- Provide functional expertise in developing BioNTech’s clinical data repository
- Collaborate with Biostatistics to develop statistical applications
- Provide programming support for regulatory submissions
- Develop data submission packages and define.xml files
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS/Base
- SAS Macro
- SAS STAT
- SAS GRAPH
- SQL
- CDISC standards
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
Manager Statistical Programming(m/w/x)
Mainz
Full-timeOn-siteExperienced
Nejo AI Summary
Statistical programming for clinical trials in oncology and infectious diseases. Advanced degree and 5+ years in pharma/CRO required. Collaboration with global programming standard library development.
Requirements
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline
- Advanced degree preferred
- 5+ years experience in pharmaceutical industry, CRO or clinical research setting
- 3+ years experience with advanced degree in pharmaceutical industry, CRO or clinical research setting
- Strong competence in SAS/Base, Macro, STAT, GRAPH, SQL
- Good understanding of FDA, EMA, ICH, and global regulations
- Solid knowledge of industry standards for clinical study data and reporting
- Solid knowledge of industry standards for reporting on clinical trials
- Solid experience of industry standards for clinical study data and reporting
- Solid experience of industry standards for reporting on clinical trials
- Solid knowledge and experience of CDISC standards
- Oncology or infectious disease therapeutic areas experience preferred
- Submission experience preferred
- Project management experience
- Detail-oriented skills
- Strong organizational skills
- Strong communication skills
- Ability to work in fast-paced environment
- Ability to work in dynamic environment
- Ability to work in team environment
- Strong analytical skills
- Strong problem-solving skills
Tasks
- Collaborate with Clinical Development team or CRO to meet project deliverables and timelines
- Perform or oversee production and validation of programming deliverables
- Anticipate resource needs and ensure long-term resource allocation
- Ensure quality control on all process and technical activities
- Participate in developing a global programming standard library
- Develop tools for efficient production and verification of derived datasets
- Provide functional expertise in developing BioNTech’s clinical data repository
- Collaborate with Biostatistics to develop statistical applications
- Provide programming support for regulatory submissions
- Develop data submission packages and define.xml files
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS/Base
- SAS Macro
- SAS STAT
- SAS GRAPH
- SQL
- CDISC standards
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
(Senior) Director Biostatistics(m/w/x)
Full-timeOn-siteSeniorMainz, Münchenfrom USD 198,900 - 298,300 / year - Boehringer Ingelheim
Internship - Statistical Methodology, Applied Statistics, and Programming in Clinical Development(m/w/x)
Full-timeInternshipOn-siteBiberach, Ingelheim am Rhein - BioNTech SE
Manager, Safety Data Analyst(m/w/x)
Full-timeOn-siteSeniorMainz, München - BioNTech SE
Statistical Expert CMC - Analytical Development(m/w/x)
Full-timeOn-siteSeniorMainz