IQVIA
Principal Statistical Programmer - FSP(m/w/x)
Full-timeOn-siteSenior
Frankfurt am Main
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FRFresenius Kabi
Senior Manager Biostatistics(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Developing biostatistical strategies and reviewing clinical study designs for pharmaceutical/biotechnology firms. 5+ years of CRO or industry experience required. Work in international, multidisciplinary teams on challenging scientific projects.
Requirements
- University degree in (Bio-)statistics or mathematics or equivalent
- At least 5 years experience in CROs and/or pharmaceutical/biotechnology industry
- Enjoyment of challenging scientific projects in international and multidisciplinary teams
- Passion for clinical development and analysis
- Comprehensive knowledge of statistical methodology in clinical research
- Motivation to explore and implement AI-supported methods
- Knowledge of Real-World research methodology
- Experience in PK/PD studies (BE studies) / adaptive designs is a plus
- Excellent knowledge of SAS
- Knowledge of R programming is a plus
- Solid understanding & implementation of CDISC requirements
- Strong communication skills for presenting methodology
- Fluent English (written & spoken)
Tasks
- Manage biostatistical solutions and strategies
- Review pre-clinical and clinical studies
- Ensure quality control for company-sponsored trials
- Guide contract research organizations
- Plan study designs and sample sizes
- Develop statistical analysis plans
- Conduct statistical analyses
- Interpret statistical results
- Contribute to clinical study reports
- Create integrated summaries for submissions
- Participate in CRF development
- Develop edit check specifications
- Create data validation plans
- Maintain programming tool standards
- Document and validate programming outputs
- Statistically program quality control outputs
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
Tools & Technologies
- SAS
- R
- CDISC
- ADaM
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi 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.
Not a perfect match?
- ICON plc
Senior Manager, Data & Applied Analytics(m/w/x)
Full-timeOn-siteManagementFrankfurt am Main - Fresenius Kabi Deutschland GmbH
Senior Manager Clinical Operations(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Fresenius SE & Co. KGaA
Senior Manager Corporate Development - Innovation Management(m/w/x)
Full-timeOn-siteManagementBad Homburg vor der Höhe - Fresenius Kabi Deutschland GmbH
Senior Manager – Business Intelligence & Strategic Projects(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhefrom USD 120,000 - 160,000 / year
FRFresenius Kabi
Senior Manager Biostatistics(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Developing biostatistical strategies and reviewing clinical study designs for pharmaceutical/biotechnology firms. 5+ years of CRO or industry experience required. Work in international, multidisciplinary teams on challenging scientific projects.
Requirements
- University degree in (Bio-)statistics or mathematics or equivalent
- At least 5 years experience in CROs and/or pharmaceutical/biotechnology industry
- Enjoyment of challenging scientific projects in international and multidisciplinary teams
- Passion for clinical development and analysis
- Comprehensive knowledge of statistical methodology in clinical research
- Motivation to explore and implement AI-supported methods
- Knowledge of Real-World research methodology
- Experience in PK/PD studies (BE studies) / adaptive designs is a plus
- Excellent knowledge of SAS
- Knowledge of R programming is a plus
- Solid understanding & implementation of CDISC requirements
- Strong communication skills for presenting methodology
- Fluent English (written & spoken)
Tasks
- Manage biostatistical solutions and strategies
- Review pre-clinical and clinical studies
- Ensure quality control for company-sponsored trials
- Guide contract research organizations
- Plan study designs and sample sizes
- Develop statistical analysis plans
- Conduct statistical analyses
- Interpret statistical results
- Contribute to clinical study reports
- Create integrated summaries for submissions
- Participate in CRF development
- Develop edit check specifications
- Create data validation plans
- Maintain programming tool standards
- Document and validate programming outputs
- Statistically program quality control outputs
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
Tools & Technologies
- SAS
- R
- CDISC
- ADaM
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi 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
Fresenius Kabi
Industry
Pharmaceuticals
Description
The company is dedicated to ensuring the excellence of packaging materials for life-saving products.
Not a perfect match?
- IQVIA
Principal Statistical Programmer - FSP(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Main - ICON plc
Senior Manager, Data & Applied Analytics(m/w/x)
Full-timeOn-siteManagementFrankfurt am Main - Fresenius Kabi Deutschland GmbH
Senior Manager Clinical Operations(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Fresenius SE & Co. KGaA
Senior Manager Corporate Development - Innovation Management(m/w/x)
Full-timeOn-siteManagementBad Homburg vor der Höhe - Fresenius Kabi Deutschland GmbH
Senior Manager – Business Intelligence & Strategic Projects(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhefrom USD 120,000 - 160,000 / year