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Senior ADS Programmer(m/w/x)
Developing and validating SDTM/ADaM datasets and statistical outputs (TLFs) from analysis plans at a global pharmaceutical company. Minimum 5 years statistical programming experience in clinical development required. Work in a highly regulated, quality-focused environment.
Requirements
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field
- Minimum 5 years statistical programming experience in clinical development, or advanced degree with 3 years equivalent experience
- Proficiency/working knowledge of modern programming language (SAS or R) and visualization/review tools
- Deep understanding of statistical quality, endpoints, QC processes
- Experience with CDISC standards (SDTM and ADaM)
- Expertise in handling/analyzing multi-modal data
- Ability to deliver programming outputs independently
- Respect for cultural differences in global workplace
- Fluency in English
- Attention to detail for regulatory submission processes/documentation
- Critical thinking, strong organizational/problem-solving skills
- Experience in cross-functional global study teams
- Effective communication skills, translating complex statistical concepts
- Experience with multiple phases of drug development
- Excellent communication skills, influencing/translating complex data
- Willingness to adapt, grow, and evolve
Tasks
- Transform statistical analysis plans into programming deliverables.
- Facilitate robust, timely, and decision-enabling analytics.
- Develop, validate, and maintain SDTM and ADaM datasets.
- Develop, validate, and maintain statistical outputs (TLFs).
- Ensure programming accuracy, traceability, and compliance.
- Develop and support programming outputs for biomarker data.
- Develop and support programming outputs for real-world data.
- Collaborate on exploratory analyses for drug development.
- Support creation and refinement of interactive analytical tools.
- Enable dynamic exploration of integrated datasets.
- Provide programming leadership for assigned studies.
- Coordinate programming deliverables with partners.
- Interpret statistical analysis plans.
- Translate plans into programming specifications.
- Ensure scientific rigor in programming outputs.
- Troubleshoot and resolve technical programming challenges.
- Proactively identify programming risks.
- Implement effective programming solutions.
- Contribute to design and maintenance of standard macros.
- Contribute to design and maintenance of reusable components.
- Document programming workflows.
- Maintain programming audit trails.
- Ensure study files are complete and traceable.
- Ensure study files are inspection-ready.
- Collaborate with stakeholders to define timelines.
- Collaborate with stakeholders to define deliverables.
- Engage in process improvement activities.
- Engage in innovation activities.
- Participate in learning activities.
- Grow knowledge of clinical research.
- Grow knowledge of programming standards.
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- CDISC
- SDTM
- ADaM
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Senior ADS Programmer(m/w/x)
Developing and validating SDTM/ADaM datasets and statistical outputs (TLFs) from analysis plans at a global pharmaceutical company. Minimum 5 years statistical programming experience in clinical development required. Work in a highly regulated, quality-focused environment.
Requirements
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field
- Minimum 5 years statistical programming experience in clinical development, or advanced degree with 3 years equivalent experience
- Proficiency/working knowledge of modern programming language (SAS or R) and visualization/review tools
- Deep understanding of statistical quality, endpoints, QC processes
- Experience with CDISC standards (SDTM and ADaM)
- Expertise in handling/analyzing multi-modal data
- Ability to deliver programming outputs independently
- Respect for cultural differences in global workplace
- Fluency in English
- Attention to detail for regulatory submission processes/documentation
- Critical thinking, strong organizational/problem-solving skills
- Experience in cross-functional global study teams
- Effective communication skills, translating complex statistical concepts
- Experience with multiple phases of drug development
- Excellent communication skills, influencing/translating complex data
- Willingness to adapt, grow, and evolve
Tasks
- Transform statistical analysis plans into programming deliverables.
- Facilitate robust, timely, and decision-enabling analytics.
- Develop, validate, and maintain SDTM and ADaM datasets.
- Develop, validate, and maintain statistical outputs (TLFs).
- Ensure programming accuracy, traceability, and compliance.
- Develop and support programming outputs for biomarker data.
- Develop and support programming outputs for real-world data.
- Collaborate on exploratory analyses for drug development.
- Support creation and refinement of interactive analytical tools.
- Enable dynamic exploration of integrated datasets.
- Provide programming leadership for assigned studies.
- Coordinate programming deliverables with partners.
- Interpret statistical analysis plans.
- Translate plans into programming specifications.
- Ensure scientific rigor in programming outputs.
- Troubleshoot and resolve technical programming challenges.
- Proactively identify programming risks.
- Implement effective programming solutions.
- Contribute to design and maintenance of standard macros.
- Contribute to design and maintenance of reusable components.
- Document programming workflows.
- Maintain programming audit trails.
- Ensure study files are complete and traceable.
- Ensure study files are inspection-ready.
- Collaborate with stakeholders to define timelines.
- Collaborate with stakeholders to define deliverables.
- Engage in process improvement activities.
- Engage in innovation activities.
- Participate in learning activities.
- Grow knowledge of clinical research.
- Grow knowledge of programming standards.
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- CDISC
- SDTM
- ADaM
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
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