Lead Clinical Data Analyst

Role Title: Programming Team Leader

Reporting To: Associate Director, Statistical Programming

Function: Data Management & Statistics

Location:Remote

Experience:4-8Years

Purpose of the Role

To ensure the accurate and timely execution of all statistical programming tasks by providing subject matter expertise and guiding a team of programmers. The role is responsible for generating statistical analyses from clinical databases, external data sources, and other relevant inputs in compliance with study protocols, statistical plans, regulatory guidelines, and internal processes to drive stakeholder satisfaction.

Key Responsibilities & KPIs

1. Subject Matter Leadership

• Provide expert guidance on SDTM and ADaM development, ensuring alignment with the latest regulatory and industry standards (e.g., CDISC).
• Resolve complex issues related to dataset creation, transformation, and validation.
• Establish and maintain best practices for programming efficiency, reproducibility, and standardization.

KPIs:

• Quality of programming deliverables (%)
• Stakeholder satisfaction (%)
• On-time task completion (%)
• Regulatory compliance (audit cases)
• Process improvements (#)
• Resolution of complex issues without escalation (#)
• Team training mandays (#)
• Voluntary attrition rate (%)
• 360° feedback results
• Training sessions conducted/attended (#)

2. Project Delivery

• Lead complex or high-priority programming tasks.
• Develop SAS programs for clinical trial outputs including TLFs, as per SAP.
• Conduct peer code reviews and optimize existing programs/macros for performance and efficiency.

3. Reporting

• Prepare comprehensive and timely management/statistical reports.
• Monitor data transfers during trials and address any issues proactively.
• Identify and escalate risks related to programming timelines and implement mitigation strategies.

4. Quality Assurance

• Establish and lead regular audits to ensure programming output and process quality.
• Execute data validation checks throughout the study lifecycle.
• Ensure accurate archiving of datasets, programs, and outputs post-study.

5. Policies, Processes & Procedures

• Maintain clear documentation of programming activities and dataset specifications.
• Ensure SOP adherence and correct any identified non-conformances.
• Implement new projects in line with department policies.
• Ensure compliance with Quality and Information Security Management Systems and applicable legal standards.

6. People Management

• Ensure technical and procedural training for all team members.
• Lead recruitment and foster team engagement and retention.
• Set team performance objectives, conduct appraisals, and provide feedback.
• Mentor team members for career growth and development.
• Recommend and support relevant training programs.

Operating Network

• Internal:

  Department Heads

• External:

  None

Role Requirements

Education:

• Bachelor’s degree in Statistics, Mathematics, Biostatistics, Data Analysis, Data Science, or a related field.
• Master’s degree in the above fields is preferred.

Experience:

• Minimum 8 years of SAS programming experience in clinical trials (CDISC standards), with at least 1–2 years of people management experience within a CRO, pharmaceutical, or related industry.

Technical / Functional Competencies:

• SAS programming and statistical software
• SDTM/ADaM development
• Regulatory compliance (e.g., FDA, EMA)
• Project management
• Quality assurance
• Documentation and data interpretation

Behavioral Competencies:

• Collaboration
• Communication
• Decision-making
• Problem-solving
• Coaching
• People management