Statistical Programming Contractor

CRISPR Therapeutics • Boston, MA

2d • $70 - $80 • Hybrid

About The Position

The Statistical Programming Contractor will provide technical support for statistical programming activities for assigned clinical studies, FDA submissions, and the development of initiatives. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

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