Senior Statistical Programmer

October 9

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000

💰 $35.2M Venture Round on 2021-03

Description

• 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 (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

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