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CRISPR Therapeutics Associate Director, Statistical Programming in Cambridge, Massachusetts

Position Summary:

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.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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