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Senior Manager Biostatistics(m/w/x)
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
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Senior Manager Biostatistics(m/w/x)
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
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Fresenius Kabi
Industry
Pharmaceuticals
Description
The company is dedicated to ensuring the excellence of packaging materials for life-saving products.
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