Senior Statistical Programmer, R/RShiny

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

📋 Description

• Utilizes R/RShiny or alternative software to create customized programming scripts for generating summary tables, data listings, graphs, and derived datasets as outlined in the statistical analysis plan and programming specifications.

• Ensures that outputs adhere to quality standards and fulfill project requirements.

• Engages in validation programming and collaborates with fellow Programmers, Biostatisticians, and other team members to address discrepancies or 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 current project documentation, including testing and verification/quality control documents and programs, ensuring readiness for inspection.

• Manages scheduling and time constraints across multiple projects, sets goals based on management priorities, and adjusts timelines or priorities by reorganizing daily tasks.

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

• Proactively identifies and addresses potential programming challenges, demonstrating foresight, establishing a foundation for efficient programming, and accurately defining all variables to be accepted with minimal rework.

• Prepares for internal meetings ahead of time, contributes ideas, and shows respect for others' opinions.

• Conducts effective internal meetings with appropriate format, frequency, and attendance.

• Distributes relevant information prior to meetings.

• Ensures that meeting minutes are promptly and accurately shared.

• Follows up on action items to ensure completion while maintaining order and focus during meetings, striving for consensus.

• Demonstrates a willingness to collaborate and assist with projects and initiatives as needed to support business objectives.

• Negotiates and establishes realistic time estimates for study programming activities with internal team members and statistical programming management, completing tasks within the designated timeframe.

• Serves as the lead statistical programmer.

• Directs the programming efforts of other personnel and monitors progress on programming deliverables.

• Reviews project documentation such as Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.

• Provides constructive feedback to relevant project team members, reflecting foresight and reducing inefficiencies in programming tasks.

• Represents statistical programming in sponsor meetings, kickoff meetings, and bid defense meetings as necessary.

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

• Transfers deliverables efficiently.

• Performs additional work-related tasks as assigned.

• Minimal travel may be required.

⛳️ Requirements

• Advanced degree in Statistics, Computer Science, or a related discipline.

• Significant experience in statistical programming within a clinical or pharmaceutical environment.

• Familiarity with CDISC programming (SDTM, ADaM).

• Experience with clinical trials and biomarker analyses.

• Proficient in R and RShiny programming languages.

• Strong grasp of statistical methods and data analysis techniques.

• Excellent problem-solving and analytical capabilities.

• Ability to work autonomously as well as collaboratively within a team.

• Strong communication and interpersonal abilities.

• SAS Certified Advanced Programmer for SAS 9 or equivalent certification preferred.

🏝️ Benefits

• We are committed to the development of our staff through career growth and advancement opportunities.

• Supportive and engaged management team.

• Technical and therapeutic area training provided.

• Peer recognition and comprehensive rewards program.

• Dedication to fostering an inclusive culture.