Remote Statistical Programming Contractor (SAS/CDISC)

CRISPR Therapeutics

Boston (MA)

Hybrid

USD 96,000 - 110,000

Full time

14 days+

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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

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

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