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 accordance with statistical analysis plans and programming specifications.

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

• Conduct validation programming and address discrepancies or findings alongside programmers, biostatisticians, and members of the project team.

• Keep project team members updated on the progress of programming tasks and any arising issues.

• Comply with relevant SOPs, work instructions, and regulatory guidelines, including ICH.

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

• Oversee scheduling and time constraints across multiple projects while adjusting workload to accommodate shifting priorities.

• Develop specifications for datasets and outputs of varying complexity, adhering to statistical and sponsor requirements.

• Proactively identify and resolve programming issues, defining variables for peer review and sponsor/requestor approval.

• Prepare for and facilitate internal meetings, disseminate information and minutes, and ensure completion of action items.

• Establish time estimates and complete study programming tasks within designated timelines.

• Serve as the lead statistical programmer, overseeing programming activities and monitoring deliverables.

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

• Actively participate as the statistical programming representative in sponsor, kickoff, and bid defense meetings.

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

• Transfer deliverables and undertake other assigned job-related responsibilities.

⛳️ Requirements

• Bachelor's degree, ideally in a scientific or statistical field; equivalent combinations of education and relevant programming experience may be accepted in lieu of a degree.

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

• Strong written and verbal communication abilities.

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

• Capability to develop custom programming code for clinical trial outputs.

• Familiarity with statistical analysis plans, programming specifications, annotated CRFs, and SAS database design.

• Understanding of applicable SOPs, work instructions, and relevant regulatory guidelines, including ICH.

• Ability to lead statistical programming activities and guide other programming personnel.

• Competence in managing multiple projects, schedules, priorities, and deadlines.

• Skill in preparing and maintaining project documentation, testing, verification, and quality control records.

• Ability to participate in sponsor, kickoff, and bid defense meetings.

• Capacity to mentor programming staff and create or deliver training materials.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Minimal travel may be required.