Senior Statistical Programmer

• Assist with development and modification of department SOPs and work instructions
• Assist with training new statistical programmers and mentor junior-level programmers
• Assist with development of study bids and changes in scope for Statistical Programming tasks
• Develop department macros to maximize efficiency and quality
• Serve as lead statistical programmer on assigned studies
• Act as primary statistical programming contact for internal and external project team members
• Work with the lead statistician to manage projects and timelines
• Identify and communicate changes in project scope and timelines
• Provide SDTM naming conventions for database build specifications
• Develop or oversee SDTM dataset specifications and assist with ADaM specifications and TLF shells
• Review and develop SDTM-annotated CRFs
• Program SAS dataset deliverables, including SDTM and ADaM datasets
• Review Open CDISC findings and generate Reviewers Guide and Define.xml files
• Review SAP and TLF shells and provide feedback to statisticians
• Program TLFs according to mock TLF shells
• Perform data transfers between SAS and databases/file formats, including reconciliations
• Review data for protocol adherence, coding consistency, and plausibility
• Perform activities according to CTI SOPs, project conventions, and GCP/ICH guidelines
• Maintain accurate work records and file statistical programming documents in the eTMF
• Provide input to and participate in departmental meetings

• At least 5 years of related statistical programming experience in a pharmaceutical or CRO environment or other relatable statistical programming experience
• Bachelor’s degree in Statistics or Biostatistics, or demonstration of excellent technical ability in statistical programming procedures
• CDISC SDTM and ADaM dataset mapping experience
• Experience with SAS dataset deliverables
• Knowledge of SDTM and ADaM dataset specifications
• Knowledge of Reviewers Guide and Define.xml files
• Ability to work according to Good Clinical Practice/ICH guidelines
• Ability to maintain accurate project records and file documents in the eTMF
• Ability to communicate with internal and external project team members

• Structured mentoring program
• Leadership courses
• Ongoing education and training
• Tuition reimbursement
• Dedicated training department
• Generous health benefits
• Vacation packages
• Hybrid work from home opportunities
• Paid parental leave
• CTI Cares program
• Work-life balance support