Principal Statistical Programmer

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

📋 Description

• Create tailored programming code utilizing SAS or alternative software to produce summary tables, data listings, graphs, and derived datasets.

• Ensure that outputs align with quality standards and project specifications.

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

• Adhere to relevant SOPs, WIs, and applicable regulatory guidelines such as ICH.

• Maintain thorough and up-to-date project documentation, testing, verification, and quality-control materials.

• Manage timelines and priorities across multiple simultaneous projects.

• Develop specifications for datasets and outputs of varying levels of complexity.

• Facilitate internal meetings, disseminate information, and ensure action items are followed through to completion.

• Deliver concurrent programming projects on schedule while providing risk-mitigation strategies.

• Oversee statistical programming efforts and guide other programming staff.

• Evaluate 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.

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

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

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

• Offer guidance and training on CDISC Standards.

• Conduct compliance reviews of CDISC deliverables, including SDTM and ADaM specifications, datasets, and DEFINE.XML.

• Engage in industry standards organizations and relay updates on standards.

• Transfer deliverables as necessary.

• Perform additional work-related tasks as assigned.

⛳️ Requirements

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

• Significant programming experience in SAS or other required software, ideally within a clinical trial context.

• Capability to lead multiple complex and/or global projects with teams of statistical programmers.

• Knowledge and practical experience in applying CDISC Standards to meet regulatory agency requirements.

• Experience with submissions to regulatory agencies is preferred.

• Background in mentoring others regarding the clinical trial process and CDISC Standards.

• Exceptional written and verbal communication skills.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• An inclusive company culture.

• Minimal travel may be required.