Senior Statistical Programmer

GQR; South San Francisco (CA); Remote; USD 80,000 - 113,000; Full time

Job summary

GQR is seeking an experienced Senior Statistical Programmer for a 6-month contract that is fully remote within the United States. The role offers a $70/hr W2 arrangement and requires strong SAS programming skills to develop, validate, and document ADaM datasets and tables for CSR deliverables.

You will work on SDTM/ADaM specifications, review SAPs and specs, and support regulatory submissions and ad hoc analyses. Collaboration with biostatistics and cross-functional teams is essential.

Qualifications

• 6+ years of SAS programming in pharma, biotech or CRO.
• CSR or regulatory submission experience (NDA/sNDA, IB, DSUR).
• Oncology experience preferred: time-to-event endpoints, RECIST, Kaplan-Meier and forest plots.
• BS/MS in Statistics, Mathematics, Computer Science, Engineering or related; MS preferred.

Responsibilities

• Program and validate ADaM datasets and TLFs for the CSR, including efficacy figures.
• Develop and validate SDTM/ADaM specifications and datasets; review SAPs, aCRFs and specs.
• Support regulatory deliverables and ad hoc analyses.
• Work directly with biostatistics and cross-functional partners.

Skills

SAS programming

CSR/regulatory submissions

Oncology experience

Statistical programming

Education

BS/MS in Statistics/Math/CS/Engineering or related; MS preferred

Tools

SAS/BASE

SAS/STAT

SAS/SQL

SAS/GRAPH

SAS Macro

Job description

Senior Statistical Programmer - 6-month contract, fully remote (US), W2

$70/hr

A commercial-stage oncology biotech needs an experienced SAS programmer to support the clinical study report for a randomized Phase III study. You will independently develop, validate and document SAS programs for ADaM datasets and tables, listings and figures in line with the SAP, CDISC standards and ICH guidance.

What you'll do

• Program and validate ADaM datasets and TLFs for the CSR, including efficacy figures
• Develop and validate SDTM/ADaM specifications and datasets; review SAPs, aCRFs and specs
• Support regulatory deliverables and ad hoc analyses
• Work directly with biostatistics and cross-functional partners

What you bring

• 6+ years of SAS programming in pharma, biotech or a CRO
• CSR or regulatory submission experience (NDA/sNDA, IB, DSUR)
• SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS Macro
• Oncology experience preferred: time-to-event endpoints, RECIST, Kaplan-Meier and forest plots
• BS/MS in Statistics, Mathematics, Computer Science, Engineering or related; MS preferred