Senior Manager, Clinical Programming (Pharmaceutical, Remote)

Job summary

The Senior Manager of Clinical Programming is tasked with establishing and governing Study Data Tabulation Model (SDTM) standards, ensuring data quality and consistency across clinical programs. This role involves oversight of programming activities and collaboration with various teams to maintain compliance with industry standards.

Qualifications

• Bachelor’s degree in Statistics, Computer Science, or Life Sciences; Master’s degree preferred.
• 6-8 years of relevant experience in the pharmaceutical, biotech, CRO, or regulatory agency sectors.
• Proficient in SAS programming with 6-8 years of experience; practical knowledge of R preferred.
• Strong understanding of clinical research, metadata management, and regulatory requirements (CDISC, FDA, ICH, GCP).
• Proven ability to manage multiple tasks and complex projects in a cross-functional environment.
• Excellent verbal and written communication skills.

Responsibilities

• Develop and implement SDTM standards to support scientific needs while ensuring compliance with CDISC and other industry standards.
• Align SDTM standards with data collection standards and relevant tools by reviewing study eCRFs and providing mapping guidance.
• Ensure compliance of SDTM datasets with regulatory submission requirements and review data packages for quality.
• Create quality control processes and metrics to ensure adherence to standards.
• Facilitate continuous process improvement and maintain high customer service levels in standards management.
• Collaborate with IT and Digital Solutions to implement technology-enabled processes for clinical trial standards.

Skills

• Strong analytical and problem-solving skills.
• Ability to work independently and effectively in a multi-disciplinary matrix environment.
• Experience in clinical data management and standards implementation preferred.

Education

• Bachelor’s degree in a relevant field; Master’s degree is a plus.

Tools

• Proficient in SAS and R programming languages; familiarity with clinical trial management systems and data standards tools.