Statistical Programming Contractor (16-Month Contract)

Crispr-Therapeutics-1; Boston (MA); Hybrid; USD 96,000 - 110,000; Full time

Benefits offered by this job

On-site 3 days/week

Remote work flexibility

Competitive hourly pay

Job summary

CRISPR Therapeutics is seeking a Statistical Programming Contractor to support SAS programming for clinical studies and FDA submissions. You will design, validate, and modify SAS programs, create CDISC datasets, and produce high-quality tables, figures and listings.

Responsibilities include collaboration with Clinical Operations, Data Management and Biostatisticians to ensure timely data analysis. A Bachelor’s in Statistics/Math/CS is required, with a Master’s preferred and 3+ years in

Qualifications

• Bachelor’s degree in Statistics, Mathematics, and/or Computer Science; Master’s degree preferred.
• Minimum 3 years of statistical programming in a pharmaceutical/biotech or CRO setting, depending on level.
• Strong knowledge of CDISC including SDTM and ADaM, metadata, terminologies, and FDA data submission readiness.
• Advanced SAS programming skills for SDTM, ADaM, Tables, Figures and Listings; experience with SAS/BASE, SAS/STAT, SAS/GRAPH and Macro language.
• Good understanding of GCP/ICH 21 CFR Part 11.

Responsibilities

• Design, develop, evaluate, validate and modify SAS programs for clinical data analysis.
• Create and validate CDISC standard datasets and related tables, figures and listings.
• Produce quality edit checks and efficient reports within timelines.
• Collaborate with Clinical Operations, Data Management and Biostatistics to support data analysis.

Education

Bachelor's degree in Statistics, Mathematics, and/or Computer Science

Master’s degree preferred

Tools

SAS/Base

SAS/STAT

SAS/GRAPH

SAS Macro language

CDISC SDTM/ADaM

Job description

Job Description:Company Overviewounded 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 SummaryThe Statistical Programming Contractor will provide technical support for statistical programming activities for assigned clinical studies, FDA submissions, and the development of initiatives.ResponsibilitiesDesign, 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 datasetsProgram 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 QualificationsBachelor’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 QualificationsStrong ability to work within cross-functional teams.Excellent interpersonal, organizational, and multi-tasking skills.CompetenciesCollaborative – Openness, One TeamUndaunted – Fearless, Can-do attitudeResults 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