Principal Stat Programmer – ADaM, TLF

This is a fully remote position, open to applicants in India.

📋 Description

• Utilize SAS or alternative software to create customized programming code for summary tables, data listings, graphs, and derived datasets in accordance with statistical analysis plans and programming specifications.

• Ensure that outputs adhere to quality standards and fulfill project requirements.

• Conduct validation programming and address discrepancies or findings in collaboration with programmers, biostatisticians, and project team members.

• Adhere to relevant SOPs, WIs, and regulatory guidelines, including ICH.

• Maintain comprehensive, up-to-date project documentation, testing, verification, and quality-control materials for inspection readiness.

• Coordinate schedules and priorities across multiple simultaneous projects.

• Create specifications for datasets and outputs of varying complexity.

• Facilitate internal meetings, disseminate information and minutes, and monitor action items.

• Deliver programming deliverables on schedule while also providing risk mitigation plans.

• Act as the lead statistical programmer, overseeing programming activities and tracking deliverables.

• Review statistical analysis plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.

• Represent statistical programming in sponsor, kickoff, and bid defense meetings.

• Mentor programming staff through training, work reviews, feedback, and guidance.

• Serve as a technical authority on clinical drug development, industry standards, and electronic submission requirements.

• Develop SOPs, guidelines, policies, and procedures with biostatistics and statistical programming teams.

• Create programming tools and macros to enhance standardization and efficiency.

• Provide training and guidance on CDISC Standards.

• Conduct compliance reviews of SDTM and ADaM specifications and datasets, as well as regulatory documents such as DEFINE.XML.

• Engage in industry standards organizations and communicate upcoming changes to standards.

• Transfer deliverables effectively.

• Execute other work-related duties as assigned.

• Minimal travel may be necessary.

⛳️ Requirements

• Bachelor's degree, ideally in a scientific or statistical field; or an equivalent combination of education and demonstrated programming experience in lieu of a degree.

• Over 8 years of programming experience in Clinical SAS, evidenced by the capability to lead multiple complex and/or global projects with teams of statistical programmers.

• Extensive experience with ADaM & TLF.

• Experience in submissions to a regulatory agency is preferred.

• Experience with pooling studies is preferred and advantageous.

• Proven experience mentoring others in the clinical trial process and CDISC Standards.

• Exceptional written and verbal communication skills.

• Proficient in reading, writing, speaking, and understanding English.

• Minimal travel may be necessary.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Commitment to an inclusive culture.

• Reasonable accommodations provided when appropriate.