Statistical Programming Contractor

CRISPR Therapeutics • South Boston, MA

1d • $70 - $80 • Hybrid

About The Position

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary The Statistical Programming Contractor will provide technical support for statistical programming activities for assigned clinical studies, FDA submissions, and the development of initiatives.

Requirements

• Bachelor’s Degree in Statistics, Mathematics, and/or Computer Science/IT background. Master’s Degree preferred.
• Minimum 3 years of statistical programming in a pharmaceutical/biotech or CRO setting (depending on level)
• 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.

Nice To Haves

• Strong ability to work within cross-functional teams.
• Excellent interpersonal, organizational, and multi-tasking skills.

Responsibilities

• Design, develop, evaluate, validate and modify computer programs using SAS to analyze and evaluate clinical data.
• Have thorough knowledge of CDISC theory and implementation guidelines, able to create and validate CDISC standard datasets
• Program edit checks and produce quality tables, figures and listings in a timely fashion and high quality.
• Work closely with Clinical Operations, Data Management and Biostatisticians on various clinical projects so that data analysis can be performed in a timely fashion.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 251-500 employees