Principal Sas Programmer

Overview

• Lead statistical programming initiatives for clinical trials, ensuring high-quality deliverables and adherence to industry standards and regulatory requirements.
• Collaborate with cross-functional teams to develop and maintain clinical trial data and reporting standards.
• Provide mentorship and technical guidance to statistical programming team members, fostering professional growth and expertise.
• Perform statistical programming and validation for phase I-IV clinical studies and regulatory submissions.
• Develop and review SDTM mapping specifications, annotated CRFs, and ADaM data specifications.
• Contribute to the development of SOPs and guidelines for statistical programming practices.
• Ensure compliance with regulatory requirements and industry conventions for clinical trial data.
• Represent the organization in interactions with sponsor companies regarding data and reporting needs.

Key Responsibilities & Duties

• Coordinate statistical programming project teams, oversee timelines, and assign programming tasks effectively.
• Develop and maintain clinical trial data and statistical reporting standards for consistency and quality.
• Perform primary statistical programming and validation for assigned projects, ensuring accuracy and compliance.
• Prepare comprehensive statistical programming documentation for regulatory submissions.
• Provide mentorship and technical supervision to team members, promoting skill development and collaboration.
• Ensure compliance with established standards and review team deliverables for quality assurance.
• Participate in developing SOPs, guidelines, and good programming practices to enhance operational efficiency.
• Lead efforts to archive statistical programming information upon project completion for future reference.

Job Requirements

• Master of Science in Computer Science or related field; PhD preferred.
• Minimum of 5 years of experience in statistical programming; 10 years preferred.
• Proficiency in SAS programming and statistical analysis, with a strong understanding of clinical trial data management.
• Experience in developing and implementing data and reporting standards for clinical trials.
• Strong leadership skills and ability to mentor team members effectively.
• Knowledge of industry standards for clinical trial data structure and presentation.
• Commitment to quality and compliance with regulatory guidelines and industry conventions.
• Excellent problem-solving and communication skills, with a collaborative mindset.