Job Description:
Company Overview
ounded 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 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.
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.
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.
Minimum Qualifications
- 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.
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. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
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.
Base pay range of $70.00 - $80.00 per hour.
The hourly rate provided is the reasonable estimate for this contract position. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
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.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
Skills Required
- Bachelor's degree in Statistics, Mathematics, Computer Science, or related IT background
- Minimum 3 years of statistical programming experience in pharmaceutical/biotech or CRO setting
- Strong hands-on SAS programming skills and experience producing SDTM, ADaM, Tables, Figures, and Listings
- Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro language
- Thorough knowledge of CDISC standards including SDTM, ADaM, metadata, controlled terminologies, and data flows
- Knowledge of industry standards for electronic submission of data to FDA
- Advanced knowledge of GCP/ICH standards and 21 CFR Part 11
- Master's degree
- Strong ability to work within cross-functional teams; excellent interpersonal, organizational, and multi-tasking skills
What We Do
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.
