morejobsParis, TX
Manager Statistical Programming
Manager Statistical Programming
Manager Statistical Programming
morejobsParis, TX
today
Other Scientific and Technical Consulting ServicesResearch and Development in Biotechnology (except Nanobiotechnology)Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Apply for this role →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 datasetsxml 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).
Also on the board Same function, level within a rung
Level
Lead
Location
Paris, TX
Occupation
Biostatisticians
Industry
Other Scientific and Technical Consulting Services
Posted
today