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

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related field.
• 7+ years of experience in clinical SAS programming, with 2+ years in a leadership or operations role.

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

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related field.
• 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).

• 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).