Principal Statistical Programmer, SDTM

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

📋 Description

• Utilizes SAS or alternative software to create customized programming code for generating summary tables, data listings, graphs, and derived datasets in accordance with the statistical analysis plan and programming specifications.

• Ensures that all outputs comply with quality standards and meet project requirements.

• Conducts validation programming and collaborates with other Programmers, Biostatisticians, and project team members to address discrepancies or any findings.

• Keeps team members updated on programming progress and any issues that require their attention.

• Adheres to relevant SOPs, WIs, and regulatory guidelines (e.g., ICH).

• Maintains organized, comprehensive, and up-to-date project documentation, testing, and verification/quality control documents and programs to ensure readiness for inspection.

• Manages scheduling and timelines across multiple projects simultaneously, prioritizes goals based on management directives, and adjusts daily workload in response to changes in timelines or priorities.

• Develops specifications for datasets and outputs of varying complexity in line with statistical and sponsor requirements.

• Proactively identifies and resolves potential programming issues, demonstrating foresight, establishing a foundation for efficient programming, and accurately defining all variables for peer review and sponsor/requestor approval with minimal rework.

• Prepares thoroughly for internal meetings, contributes ideas, and shows respect for the opinions of others.

• Conducts effective internal meetings, ensuring they are appropriately formatted, frequent, and well-attended.

• Distributes pertinent information beforehand and ensures that minutes are accurately and promptly shared. Monitors action items to completion, maintaining order and focus during meetings and striving for consensus.

• Demonstrates a willingness to collaborate with others and assist with projects and initiatives as needed to fulfill business requirements.

• Negotiates and sets accurate time estimates for completing study programming tasks with internal team members and statistical programming management, ensuring that project programming activities are completed within the allocated timeframe.

• Serves as the lead statistical programmer, overseeing the programming activities of other personnel and tracking progress on programming deliverables.

• Reviews project documentation, including the Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design.

• Provides constructive feedback to the appropriate project team members, showcasing foresight and minimizing inefficiencies in programming tasks.

• Represents statistical programming in sponsor meetings, kickoff meetings, and bid defense meetings, as required by the sponsor.

• Aids in mentoring programming personnel by developing training courses, presenting training materials, reviewing work, and guiding new associates through processes.

• Transfers deliverables effectively.

• Undertakes other work-related duties as assigned.

⛳️ Requirements

• Bachelor's degree, preferably in a scientific or statistical field;

• Extensive programming experience in SAS or other necessary software, ideally in a clinical trial setting.

• Exceptional written and verbal communication abilities.

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

🏝️ Benefits

• We are dedicated to the development of our personnel through career advancement opportunities;

• Supportive and engaged line management;

• Training in technical and therapeutic areas;

• Peer recognition and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.

• Driven to Deliver, capturing the passion of our colleagues to come to work every day and create solutions that can significantly affect someone's life.

• We are a growing global company committed to advancing our talent beyond their initial roles.