Statistical Programming Contractor (16-Month Contract)

CRISPR Therapeutics; Boston (MA); On-site; USD 96,000 - 110,000; Full time

Job summary

CRISPR Therapeutics seeks a Statistical Programming Contractor to support statistical programming activities for assigned clinical studies, FDA submissions, and related initiatives.

You will design, develop, validate and modify SAS programs to analyze data, create CDISC standard datasets, and produce quality tables, figures and listings through collaboration with Clinical Operations and Biostatistics.

Qualifications

• Bachelor’s Degree in Statistics, Mathematics, and/or Computer Science/IT background (Master’s preferred).
• Minimum 3 years of statistical programming experience in pharma/biotech/CRO.
• Strong knowledge of CDISC SDTM/ADaM, metadata, terminologies and FDA data submission processes.
• Proficient SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro language.

Responsibilities

• Design, develop, evaluate, validate and modify SAS programs for clinical data analysis.
• Create and validate CDISC standard datasets.
• Program edit checks and produce quality tables, figures, and listings in a timely manner.
• Collaborate with Clinical Operations, Data Management and Biostatistics on projects to enable timely data analysis.

Skills

Statistical programming

CDISC knowledge

SAS programming

GCP/ICH knowledge

Education

Bachelor’s Degree in Statistics, Mathematics, or Computer Science/IT

Master’s Degree preferred

Tools

SAS

Job description

Job Description:

Company Overview

ounded over a decade ago,CRISPR Therapeuticsis 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 Therapeuticsis 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 Therapeuticshas established strategic collaborations with leading biopharmaceutical partners, includingVertex Pharmaceuticals.CRISPR Therapeutics AGis headquartered inZug,Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan 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 3years 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.