Principal Statistical Programmer

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

📋 Description

• Create tailored programming code utilizing SAS or other software to produce summary tables, data listings, graphs, and derived datasets in accordance with statistical analysis plans and programming specifications.

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

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

• Keep project team members updated on programming progress and any issues that arise.

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

• Maintain comprehensive, up-to-date project documentation, testing, verification, quality control documents, and programs to ensure inspection readiness.

• Manage timelines and constraints across multiple concurrent projects effectively.

• Develop specifications for datasets and outputs of varying complexities.

• Organize internal meetings, disseminate information and minutes, and ensure completion of action items.

• Deliver concurrent programming outputs punctually and offer risk mitigation strategies.

• Act as the lead statistical programmer, oversee programming activities, and monitor 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 review, feedback, and guidance.

• Serve as a technical authority on clinical drug development, industry standards, electronic submissions, CDISC, SDTM, and ADaM.

• Conduct compliance reviews of CDISC deliverables and regulatory documents like DEFINE.XML.

• Engage in industry standards organizations and keep the Biometrics Department informed on changes in standards.

• Transfer deliverables and undertake other assigned work-related tasks.

⛳️ Requirements

• Bachelor's degree, ideally in a scientific or statistical field; an equivalent combination of education and proven programming experience may substitute for a degree.

• Significant programming expertise in SAS or other required software, preferably in a clinical trial setting.

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

• Familiarity with CDISC Standards for regulatory agency requirements.

• Preferred experience in submissions to a regulatory agency.

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

• Exceptional written and verbal communication abilities.

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

• Occasional travel may be necessary.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive company culture.

• Reasonable accommodations available when appropriate.