About the Role
Lead statistical programming activities for oncology studies, ensuring high-quality outputs and adherence to regulatory standards while mentoring junior staff and collaborating with cross-functional teams.
Responsibilities
- Oversee development and validation of analysis datasets, tables, listings, and figures for oncology trials
- Ensure programming deliverables meet protocol, statistical analysis plan, and regulatory requirements
- Collaborate with biostatisticians and data management to define programming specifications
- Mentor and guide less experienced programming staff
- Review programming code for accuracy, efficiency, and compliance with standards
- Lead programming contributions to study reports and regulatory submissions
- Support validation of programming outputs by providing documentation and traceability
- Ensure consistency with CDISC standards including SDTM and ADaM
- Participate in project planning and timeline estimation for programming tasks
- Troubleshoot complex programming issues and implement effective solutions
- Maintain up-to-date knowledge of industry guidelines and regulatory expectations
- Promote best practices in programming processes and tools
- Coordinate with external vendors when third parties are involved in programming work
- Ensure audit readiness of programming artifacts and documentation
- Participate in system and process improvement initiatives
Compensation
Competitive market rate commensurate with experience
Work Arrangement
Remote within the United States
Team
Biopharmaceutical services provider focused on clinical development
Why This Role Matters
- This position plays a critical role in delivering high-quality statistical programming outputs that support regulatory filings and clinical decision-making in oncology.
- The consultant will influence best practices and contribute to the technical excellence of programming deliverables across studies.
Growth Opportunities
- Opportunities exist for professional development through leadership in complex studies and exposure to innovative trial designs.
- The role supports career advancement through technical mastery and mentorship responsibilities.
Not available
