Senior Statistical Programmer

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

📋 Description

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

• Ensure that outputs adhere to quality benchmarks and project requirements.

• Conduct validation programming and address any discrepancies or findings in collaboration with Programmers, Biostatisticians, and project team members.

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

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

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

• Oversee schedules and time constraints across various projects.

• Create specifications for datasets and outputs of diverse complexity.

• Proactively identify and resolve programming challenges and define variables for peer review and sponsor/requestor approval.

• Prepare for and lead internal meetings, disseminate information and minutes, and track action items.

• Negotiate time estimates and complete study programming tasks within designated timeframes.

• Serve as the lead statistical programmer, oversee other programming staff, and monitor programming deliverables.

• Review project documentation and provide insights to enhance programming efficiency.

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

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

• Transfer deliverables and perform other assigned work-related responsibilities.

⛳️ Requirements

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

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

• Strong written and verbal communication skills.

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

• Capability to develop custom programming code for summary tables, data listings, graphs, and derived datasets.

• Familiarity with statistical analysis plans and programming specifications.

• Understanding of validation programming and quality control processes.

• Knowledge of applicable SOPs, WIs, and relevant regulatory guidelines, including ICH.

• Ability to manage multiple projects, schedules, and shifting priorities effectively.

• Proficiency in leading statistical programming activities and overseeing deliverables.

• Competence in reviewing Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.

• Experience in participating in sponsor, kickoff, and bid defense meetings.

• Ability to mentor programming personnel and create or deliver training materials.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Collaboration with colleagues from around the globe.

• Occasional travel may be required.