Senior Statistical Programmer

October 17

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Description

• Precision for Medicine is hiring a Senior Statistical Programmer to join our global team! • Perform clinical study programming in accordance with the study budget and scope of work. • Use strong interpersonal and organizational skills to set and achieve both contracted and financial objectives. • Support (and/or lead) SAS programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet project needs. • Provide technical expertise to the development of programming standards and procedures. • 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 for SAS programs and other study documents. • Review, maintain and approve study documents per standard procedures. • Interact with clients and lead statistical programming efforts for the project team. • Prepare reports 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.

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.