Statistical Programming Contractor (16-Month Contract)
About the Company
Founded over a decade ago, 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 advances 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. CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. Headquarters are in Zug, Switzerland, with U.S. operations based in Boston, Massachusetts, and San Francisco, California.
About the Role
The Statistical Programming Contractor will provide technical support for statistical programming activities for assigned clinical studies, FDA submissions, and the development of initiatives.
Responsibilities
- Design, develop, evaluate, validate, and modify computer programs using SAS to analyze and evaluate clinical data.
- Apply thorough knowledge of CDISC theory and implementation guidelines to create and validate CDISC standard datasets.
- Program edit checks and produce quality tables, figures, and listings in a timely fashion.
- Work closely with Clinical Operations, Data Management, and Biostatisticians on various clinical projects to ensure timely data analysis.
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.
- Strong knowledge of CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as industry standards for electronic submission of data to the FDA.
- Strong hands-on SAS programming skills and experience with clinical trial reporting for SDTM, ADaM, tables, figures, and listings.
- Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS Macro language.
- Advanced knowledge of GCP/ICH standards and 21 CFR Part 11.
Preferred Qualifications
- Strong ability to work within cross-functional teams.
- Excellent interpersonal, organizational, and multi-tasking skills.
Competencies
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission with a sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive, ownership mindset.
Work Environment
CRISPR Therapeutics fosters a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Employees work at least three days on-site to cultivate mentorship opportunities, increase cross-functional communication, and foster connections. Certain lab-based and manufacturing positions are fully on-site.
Pay
Base pay range of $70.00 - $80.00 per hour. The hourly rate provided is a reasonable estimate for this contract position and will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.