Senior Manager, Statistical Programming / Senior Manageress, Statistical Programming

Join Our Team as a Sr. Manager, Statistical Programming

Are you ready to lead the statistical programming strategy behind innovative clinical development programs and global regulatory submissions? Proclinical is seeking a Sr. Manager, Statistical Programming to 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).

How to Apply

If you are interested in this exciting opportunity, please apply online using the form below. Please note that only applications matching the job profile will be considered.

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