Statistical Programmer Jobs

About The Position

Requirements

• Bachelor's degree in Statistics, Epidemiology, or a related quantitative discipline and 5 or more years of progressive, relevant experience; or a master's degree in a related field and 3 or more years of progressive, relevant experience.
• Advanced knowledge of SAS.
• Experience with statistical software packages such as R or Python.
• Problem-solving mindset.
• Working knowledge of CRF and database structure, including attribute assignment and logic checking.
• Knowledge of FDA regulatory requirements for IDE, BLA, PMA, and 510(k) submissions, as well as GCP and ICH guidelines.
• Knowledge of infectious disease, cancer, genomics, and common public health issues.
• Experience in technical writing.
• Working knowledge of basic statistics.
• Ability to implement statistical concepts in clear, efficient code for data analysis and reporting.

Responsibilities

• Develop and validate programs that generate analysis datasets, tables, figures, and listings according to the statistical analysis plan and programming specifications.
• Ensure outputs meet quality standards and project requirements.
• Keep project team members informed about programming progress and issues requiring their attention.
• Work with Clinical Affairs project team members to ensure CRF and database design meets analysis needs.
• Provide ad-hoc requests and reports to monitor trial progression and address project team needs.
• Manage schedules and time constraints across multiple projects, adjusting workload when timelines or priorities change.
• Maintain expertise in current programming techniques and learn new techniques.
• Review and approve study-specific documents.
• Provide input on Data Management SOPs and Statistical Programming SOPs and work instructions.
• Recommend and implement continuous process improvement ideas.
• Develop and maintain programming specifications according to the statistical analysis plan.
• Assist in training and mentoring new or junior team members.
• Perform other function-related activities as reasonably required by business needs.

Benefits

• Comprehensive training upon joining and continued development and training throughout the career.
• Bonus eligible.