Precision Medicine Group is hiring a
Statistical Programmer

Summary

Join Precision for Medicine as a Senior Statistical Programmer to support clinical study programming in accordance with the study budget and scope of work. You will use your strong interpersonal and organizational skills to set and achieve both contracted and financial objectives in the execution of the programming.

Requirements

• Minimum 5 years SAS programming experience
• Previous SAS statistical programming experience working in Clinical Trials (in CRO, Biotech, Pharmaceutical company or related fields)
• Certified Advanced Programmer for SAS 9 or equivalent proficiency preferred
• Some experience with Oncology and Rare Diseases would be an advantage
• Some experience with ISS/ISE programming and submissions would be desirable
• Bachelor's degree in Statistics, Mathematics, Computer Science, or in a related field
• Knowledge of industry standards, such as ICH guidelines, CDISC data structures, 21 CFR Part 11 and FDA guidelines

Responsibilities

• Review CRFs, edit check specifications and table mock-ups
• Create specifications for SDTM and ADaM datasets
• Generate blankcrf.pdf aCRFs and define.xml files
• Generate SDTM and ADaM datasets, tables, listings, and figures to support the analysis of clinical trials data
• Carrying out Lead statistical programming work on clinical studies
• Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Perform quality control (including documentation) for SAS programs and other study documents (e.g., presentations and reports)
• Review, maintain and approve study documents per standard procedures
• Interact with clients and lead statistical programming efforts for the project team; perform preliminary review to aid the senior level review for analysis package deliveries
• Prepare reports (i.e. patient profiles, SAP related outputs, interim analysis) for Data Monitoring Committees (DMCs)
• Assist with training of new hires; provide ongoing training and mentorship for statistical programmers
• Participate in the development and maintenance of departmental procedures/standards
• Program, test and document global utility programs and tools in accordance with standards and validation procedures
• Provide technical oversight and leadership when needed for analysis and reporting
• Mentoring more junior team members as required

Benefits

Equal Opportunity Employer