Statistical Programming Contractor (16-Month Contract)

CRISPR Therapeutics•South Boston, MA

7d•Hybrid

About The Position

CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY ® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, 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 . 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.
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

Master’s Degree preferred.
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.