CRISPR Therapeutics Associate Director, Statistical Programming in Cambridge, Massachusetts
The Associate Director may manage Statistical Programming staff and provide technical support for statistical programming activities for assigned clinical studies, FDA submission and development of initiatives. He/she provides an expert-level hands-on support and technical leadership to all clinical development programs and regulatory submissions
Duties and Responsibilities:
Effectively design and develop SAS programs for multiple clinical projects, consistently meeting objectives of the clinical development program.
Manage Statistical Programming activities to assure they meet timeline, budget, and quality expectations, through effective leadership, as well as the work performance.
Provide leadership to ensure compliance with CRISPR SOP's and FDA/ICH/GCP regulations and project management in cross-functional teams.
Support technical and professional development of direct reports.
Inspire and Motivates people to do their best.
Provide expert technical leadership of process and methodology development work with regard to SP standards and validation procedures.
Education/Skills and Experience Requirements:
Bachelor?s Degree in Statistics, Mathematics, and/or Computer Science/IT background. Master?s Degree preferred.
Minimum 10 years of statistical programming in a pharmaceutical/biotech or CRO setting.
Strong knowledge in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.
Strong hands-on SAS programing skills and working experience for clinical trial reporting for SDTM, ADaM, Table, figure, and Listing.
Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro language.
Advanced knowledge of GCP/ICH standards, 21 CFR Part 11.
Strong leadership skills and ability to work within cross-functional teams.
Excellent interpersonal, organizational, and multi-tasking skills.
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