Statistical Programming Contractor (16-Month Contract)

CRISPR Therapeutics; Boston, Northern (MA, KY); Hybrid; USD 96,000 - 110,000; Full time

Job summary

CRISPR Therapeutics in Boston, MA is seeking a Statistical Programming Contractor to support SAS programming for assigned clinical studies, FDA submissions, and related initiatives. You will design, validate, and maintain programs that analyze clinical data and generate quality tables, figures, and listings.

Collaborate with Clinical Operations, Data Management and Biostatistics; bring strong CDISC SDTM/ADaM knowledge and SAS proficiency; familiarity with GCP/ICH and FDA submission standards is

Qualifications

• Bachelor’s degree in Statistics, Mathematics and/or Computer Science/IT.
• 3+ years of statistical programming in pharma/biotech or CRO.
• Strong SAS programming for SDTM/ADaM tables, listings, figures.
• Knowledge of CDISC standards and FDA submissions.
• Experience with CDISC metadata and data flows is a plus.

Responsibilities

• Design, develop, validate and modify SAS programs to analyze clinical data.
• Create and validate CDISC SDTM/ADaM datasets and generate tables, figures and listings.
• Work closely with Clinical Operations, Data Management and Biostatisticians to ensure timely data analysis.
• Support data management and submission activities for FDA and internal reviews.

Skills

SAS programming

CDISC SDTM/ADaM

Clinical trial data analysis

SAS Macro / BASE/STAT/GRAPH

GCP/ICH 21 CFR Part11

Education

Bachelor's Degree in Statistics/Mathematics/Computer Science/IT

Job description

Company Overview

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 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, 21CFR Part11.

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.

Company Culture

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

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research‑stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize‑winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies 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, and business offices in London, United Kingdom.

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