Operations Manager - Clinical SAS Programming

Job Summary :

We are seeking a detail-oriented and proactive Operations Manager to oversee the day-to-day operations of our Clinical SAS Programming team. This role is critical in ensuring the timely delivery of programming outputs, optimizing team workflows, and supporting cross-functional collaboration across clinical development, biostatistics, and data management.

Key Responsibilities :

Operational Oversight :

- Manage timelines, resource allocation, and deliverables for clinical programming projects.

- Track progress against milestones and proactively address risks or delays.

- Ensure compliance with regulatory standards (CDISC, FDA, ICH-GCP).

Team Coordination :

- Facilitate communication between programmers, statisticians, and data managers.

- Support onboarding, training, and performance tracking of programming staff.

- Promote a culture of accountability, collaboration, and continuous improvement.

Process & Quality Management :

- Implement and maintain SOPs, workflows, and documentation standards.

- Drive automation and efficiency improvements in programming operations.

- Monitor quality metrics and ensure audit readiness.

Stakeholder Engagement :

- Serve as the point of contact for operational updates to leadership and project teams.

- Coordinate with global teams to align on priorities and resource needs.

- Support strategic planning and capacity forecasting.

Qualifications :

Education & Experience :

- 7+ years of experience in clinical SAS programming, with 2+ years in a leadership or operations role.

Skills & Competencies :

- Good understanding of clinical trial processes and CDISC standards (SDTM, ADaM).

- Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira).

- Excellent organizational, communication, and problem-solving skills.

- Ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications :

- PMP or similar project management certification.

- Experience working in a CRO or pharmaceutical company.

- Familiarity with regulatory submission processes (e.g., eCTD, define.xml).