Lead Statistical Programmer

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

📋 Description

• Create and coordinate SAS programs, outputs, and study reports for clinical trial projects.

• Conduct quality control on statistical outputs independently to ensure First Time Right results.

• Serve as the lead programmer and/or subject matter expert for complex studies.

• Manage project assignments and programming teams as the main contact for Project Management and sponsor teams.

• Ensure adherence to ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and internal protocols.

• Engage in project kick-off meetings to comprehend the scope, plans, timelines, and specific project requirements.

• Create and/or validate CDISC Data Standards specifications and programming for moderately complex studies.

• Develop and/or validate programming for the integration of databases from various studies and sources.

• Create, validate, and document statistical programs for tables, figures, and listings.

• Generate or review Define packages (Define.xml) and Reviewer Guides according to CDISC Data Standards.

• Maintain, verify, and ensure the quality and accuracy of assigned tasks.

• Complete training documentation specific to clients and the organization punctually.

• Anticipate team workload and provide clarity and direction on project objectives, milestones, and upcoming initiatives.

• Assist with SAS programs, macros, templates, and utilities for data cleaning and reporting purposes.

• Conduct reconciliation of external data.

• Offer advanced technical expertise with minimal oversight for clinical data analysis and reporting.

• Mentor associates and facilitate training for trainees and team members.

• Provide recommendations for process improvements to enhance efficiency and align processes with regulatory and industry standards.

• Regularly assess team members and offer constructive feedback.

• Support internal or external audit requirements and quality/process improvement initiatives.

• Carry out other responsibilities as assigned by the Department Head or Immediate Supervisor.

⛳️ Requirements

• A bachelor's or master's degree in computer science, engineering, mathematics, statistics, or a life science field is preferred.

• At least 8-10 years of relevant SAS programming experience across all phases of clinical trials.

• Capability to perform SAS programming independently.

• Solid understanding of all phases of clinical trials.

• Experience working in various therapeutic areas.

• Proficient in clinical industry standards, CDISC Data standards, ICH-GCP Regulatory guidelines, medical terminology, and clinical trial methodologies.

• Exceptional verbal and written communication skills.

🏝️ Benefits

• Employee position.

• Remote work arrangement.