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Lead the statistical programming team, overseeing resource management, project delivery, and process efficiencies. Ensure that the team’s activities align with business priorities, provide technical expertise to develop programming standards and procedures, and maintain a high-performing, compliant, and collaborative environment across global functions. This role requires close interaction with cross-functional teams including Biostatistics, Data Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Commercial, as well as vendors and CROs.
Job Responsibility:
Lead and manage the statistical programming team to ensure optimal use of resources, adherence to timelines, and achievement of departmental and organizational goals
Ensure infrastructure, staffing, and training plans support project completion on time and within budget
Provide accurate forecasting for annual budgets and manage financial performance throughout the year
Mentor, coach, and develop team members to maximize performance and career growth
Maintain complete and auditable documentation of all programming activities and oversee CRO/vendor deliverables
Provide statistical programming support for regulatory submissions, exploratory analyses, and ad-hoc requests
Manage development, testing, and documentation of global utility programs and tools per standards and validation procedures
Participate in creation, implementation, and maintenance of departmental procedures and standards
Facilitate communication and collaboration across cross-functional teams and ensure alignment with legal, compliance, and regulatory requirements
Champion the “ONE Team” approach to foster collaboration and focus on patient and customer priorities
Maintain a positive, results-oriented work environment, modeling teamwork, open communication, and corporate values
Requirements:
15+ years of experience in statistical programming within Biotechnology, Pharmaceutical, or CRO environments
5+ years in a leadership role
Prior experience managing a statistical programming team
Expert in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS, and R
Deep understanding of ICH guidelines, CDISC standards, 21 CFR Part 11, FDA and EMA regulations, and global drug development processes
Experience with eCTD NDA submissions
Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field
Master’s preferred
Exceptional organizational, multi-tasking, and problem-solving skills
Strong interpersonal and communication skills
Ability to work independently and collaboratively, adapt to change, and drive process improvements
What we offer:
Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development