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Leading statistical programming for clinical studies, delivering validated SDTM and ADaM datasets at global healthcare solutions developer. 8+ years statistical programming in clinical development, with proven leadership ability, required. Global impact on healthcare access.
Requirements
- Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field
- Minimum 8 years statistical programming experience in clinical development, or advanced degree with 6 years equivalent experience
- Proven ability to lead programming efforts
- Expertise in modern programming languages (R, Python) and review/visualization tools (SAS)
- Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements
- Expertise in handling/analyzing multi-modal data
- Deep expertise in statistical quality, endpoints, QC processes
- Respect for cultural differences in global workplace
- Fluent English and excellent communication skills
- Experience preparing eCTD submissions and working with regulatory authorities
- Involvement in automation or advanced analytics projects (AI/ML)
- Ability to coach and mentor colleagues
- Strong systems thinking and awareness of enterprise data/technology landscape
- Experience in cross-functional global study teams
- Experience with multiple phases of drug development
- Excellent communication, influence, and data translation skills
Tasks
- Lead statistical programming for studies and submissions.
- Lead programming for research efforts.
- Deliver validated SDTM and ADaM datasets.
- Deliver validated tables, listings, and figures.
- Integrate and analyze diverse data types.
- Enable deeper scientific insights.
- Collaborate on exploratory analyses.
- Generate hypotheses from data.
- Support data-driven decision-making.
- Lead development of data insights engines.
- Lead development of analytical applications.
- Visualize complex datasets.
- Enable dynamic data exploration.
- Develop innovative programming solutions.
- Implement automation and scalable approaches.
- Improve programming efficiency and reliability.
- Translate statistical analysis plans.
- Develop executable programming strategies.
- Ensure accurate analytical intent in outputs.
- Apply problem-solving and technical rigor.
- Drive standardization and reuse of code.
- Develop programming libraries and frameworks.
- Ensure inspection readiness and documentation.
- Maintain traceable workflows and audit trails.
- Adhere to internal and regulatory standards.
- Contribute to functional improvement initiatives.
- Enhance tools, templates, and best practices.
- Elevate quality and operational excellence.
- Ensure execution quality and timely delivery.
- Adhere to programming standards and strategy.
- Mentor less experienced colleagues.
- Promote software development best practices.
- Promote analytics tooling best practices.
- Foster scientific collaboration.
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- R
- Python
- SAS
- CDISC
- SDTM
- ADaM
- eCTD
- AI
- ML
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Leading statistical programming for clinical studies, delivering validated SDTM and ADaM datasets at global healthcare solutions developer. 8+ years statistical programming in clinical development, with proven leadership ability, required. Global impact on healthcare access.
Requirements
- Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field
- Minimum 8 years statistical programming experience in clinical development, or advanced degree with 6 years equivalent experience
- Proven ability to lead programming efforts
- Expertise in modern programming languages (R, Python) and review/visualization tools (SAS)
- Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements
- Expertise in handling/analyzing multi-modal data
- Deep expertise in statistical quality, endpoints, QC processes
- Respect for cultural differences in global workplace
- Fluent English and excellent communication skills
- Experience preparing eCTD submissions and working with regulatory authorities
- Involvement in automation or advanced analytics projects (AI/ML)
- Ability to coach and mentor colleagues
- Strong systems thinking and awareness of enterprise data/technology landscape
- Experience in cross-functional global study teams
- Experience with multiple phases of drug development
- Excellent communication, influence, and data translation skills
Tasks
- Lead statistical programming for studies and submissions.
- Lead programming for research efforts.
- Deliver validated SDTM and ADaM datasets.
- Deliver validated tables, listings, and figures.
- Integrate and analyze diverse data types.
- Enable deeper scientific insights.
- Collaborate on exploratory analyses.
- Generate hypotheses from data.
- Support data-driven decision-making.
- Lead development of data insights engines.
- Lead development of analytical applications.
- Visualize complex datasets.
- Enable dynamic data exploration.
- Develop innovative programming solutions.
- Implement automation and scalable approaches.
- Improve programming efficiency and reliability.
- Translate statistical analysis plans.
- Develop executable programming strategies.
- Ensure accurate analytical intent in outputs.
- Apply problem-solving and technical rigor.
- Drive standardization and reuse of code.
- Develop programming libraries and frameworks.
- Ensure inspection readiness and documentation.
- Maintain traceable workflows and audit trails.
- Adhere to internal and regulatory standards.
- Contribute to functional improvement initiatives.
- Enhance tools, templates, and best practices.
- Elevate quality and operational excellence.
- Ensure execution quality and timely delivery.
- Adhere to programming standards and strategy.
- Mentor less experienced colleagues.
- Promote software development best practices.
- Promote analytics tooling best practices.
- Foster scientific collaboration.
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- R
- Python
- SAS
- CDISC
- SDTM
- ADaM
- eCTD
- AI
- ML
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Roche
Industry
Healthcare
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
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