Similar Jobs
See allStatistical Programmer Consultant
Kyverna Therapeutics
US
SAS
CDISC
SDTM
Senior/Principal Statistician Consultant
ClinChoice
US
SAS
R
CDISC Standards
Senior Statistical Programmer/Analyst Consultant (TA - Gene Therapy) - Remote United States
ClinChoice
US
SAS
CDISC
SDTM
Senior Manager, Statistical Programming
Immunovant, Inc.
US
SAS
SDTM
ADaM
Senior Clinical & Statistical Programmer
Jobgether
US
SAS
CDISC
SDTM
Position Overview:
- We are seeking an experienced Principal Statistical Programmer to provide programming expertise and leadership in support of clinical development programs, primarily focused on solid tumor oncology studies.
- The ideal candidate will have extensive experience in clinical trial statistical programming, strong SAS programming skills, and in-depth knowledge of oncology endpoints, CDISC standards, and regulatory submission requirements.
Key Responsibilities:
- Lead and oversee statistical programming activities for oncology clinical trials, with a primary focus on solid tumor indications.
- Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards.
- Support oncology efficacy and safety analyses, including Overall Survival, Progression-Free Survival, and Objective Response Rate.
Required Qualifications:
- Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline.
- Extensive experience in clinical statistical programming within the pharmaceutical or biotechnology industry.
- Strong hands-on experience with SAS programming, including SAS Base, SAS Macro, and SAS/STAT.
ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries and a culture focused on quality, professional development, and supportive culture.