Sr. Manager, Statistical Programming
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Ready to lead the statistical programming strategy behind innovative clinical development programmes and global regulatory submissions?
Proclinical is seeking a Sr. Manager, Statistical Programming to lead and provide technical expertise across multiple clinical development programs within a specific therapeutic area. This is a full-time position with the flexibility to work remotely.
Responsibilities:
- Lead statistical programming activities for multiple clinical studies and development programs.
- Ensure timely delivery of high-quality programming deliverables, whether produced internally or by external vendors.
- Maintain consistency in processes, standards, and execution of programming activities across assigned studies.
- Support and oversee programming activities related to global regulatory submissions and responses to health authorities.
- Manage outsourced programming activities, ensuring adherence to quality, budget, and timelines.
- Review and supervise the production of programming deliverables, including:
- Tables, Listings, and Figures (TLFs)
- SDTM and ADaM datasets
- xml files and associated documentation
- Contribute to the development, implementation, and continuous improvement of programming standards, SOPs, validation processes, and best practices.
- Maintain study documentation in compliance with regulatory requirements, ensuring audit and inspection readiness.
- Identify opportunities to optimize workflows, promote innovative approaches, and address programming needs for increasingly complex study protocols and methodologies.
Key Skills and Requirements:
- Advanced proficiency in SAS programming within a clinical research environment.
- Strong knowledge of CDISC standards, including SDTM and ADaM.
- Proven experience in developing and programming SDTM and ADaM datasets.
- Expertise in generating reports, TLFs, and other statistical outputs.
- Experience supporting clinical development programs and trials.
- Familiarity with regulatory submission processes (e.g., NDA, sNDA, or equivalent).
- Strong collaboration and communication skills, with the ability to work effectively in multidisciplinary and international teams.
- Proactive stakeholder management and decision-making abilities.
- Excellent planning, organizational, and prioritization skills.
- Ability to mentor, train, and influence team members and project teams.
- Knowledge of R or other statistical programming tools is a plus.
- Solid understanding of the clinical data lifecycle and data management processes.
- Educational background in Statistics, Mathematics, Computer Science, Life Sciences, or a related field (Master's degree preferred; Bachelor's degree considered with relevant experience).
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