Statistical Programmer

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

📋 Description

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

• Ensure that outputs align with quality standards and fulfill project requirements.

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

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

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

• Oversee scheduling and prioritize tasks across multiple simultaneous projects.

• Develop specifications for datasets and outputs of varying complexities.

• Facilitate internal meetings, disseminate information, document minutes, and keep track of action items.

• Deliver concurrent programming projects within deadlines and provide risk-mitigation strategies.

• Serve as the lead statistical programmer, guiding programming activities and monitoring 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 personnel through training, work reviews, feedback, and guidance.

• Act as a technical expert in clinical drug development, industry standards, electronic submissions, CDISC, SDTM, and ADaM.

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

• Engage in industry standards organizations and provide updates on changes in standards.

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

• Contribute technical expertise to programming tools and macros.

• Transfer deliverables efficiently.

• Execute other assigned work-related duties.

⛳️ Requirements

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

• Extensive programming experience in SAS or other required software, preferably within a clinical trial setting.

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

• Knowledge and experience with CDISC Standards for regulatory agency compliance.

• Prior experience in submissions to a regulatory agency is preferred.

• Experience in mentoring others regarding 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 management.

• Technical and therapeutic area training provided.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations offered when appropriate.