Katalyst CRO
Join to apply for the Principal Statistical Programmer role at Katalyst CRO
1 week ago Be among the first 25 applicants
Join to apply for the Principal Statistical Programmer role at Katalyst CRO
Get AI-powered advice on this job and more exclusive features.
- Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.
- Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.
- Following specifications, develops algorithms and writes programs to create datasets.
- Produces data listings, summary tables and graphs using SAS software.
- Independently check data listings, summary tables and graphs.
- Imports and exports SAS data.
- Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
- Plays an active role in taking project solutions and generalizing them for the Biostatistics group.
- Interact with the project statistician and guides other programmers participating on a project team.
- Experience with Pooled analysis, regulatory agencies requirements and e-submission experience.
- Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.
- Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.
- Following specifications, develops algorithms and writes programs to create datasets.
- Produces data listings, summary tables and graphs using SAS software.
- Independently check data listings, summary tables and graphs.
- Imports and exports SAS data.
- Assists data management group in performing data edit checks.
- Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
- Plays an active role in taking project solutions and generalizing them for the Biostatistics group.
- Interact with the project statistician and guides other programmers participating on a project team.
- Experience with Pooled analysis, regulatory agencies requirements and e-submission experience.
- Minimum of 10+ years of statistical programming experience in the life science industry and relevant bachelor's degree
- Must have recent NDA submissions experience.
- ISS/Client safety & efficacy experience is required.
- Experience creating define.xml and experience with Pinnacle 21 and specifications.
- SAS Certified Base and/or Advance Programmer experience is preferred.
- Proven experience in SAS programming including base SAS, SAS/Stat, SAS/Graph, macros, ODS.
- Experience with SDTM and ADaM industry data standards.
- Good communication skills and attention to detail are crucial.
- Proven ability to handle multiple tasks.
- Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Contract
Job function
Job function
Information Technology-
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x
Get notified about new Statistical Programmer jobs in Atlanta, GA .
Quantitative Analyst, Quantitative Research
Sr Analyst, Forecasting - CNN Data Analytics, Science & Insights
Atlanta, GA $75,390.00-$140,010.00 4 days ago
Atlanta Metropolitan Area $90.00-$100.00 16 hours ago
ASSOCIATE DATA SCIENTIST - Insights - Search
Graduate Intern, Data Scientist - Technical Operations (Spring 2026)
Decision Scientist - Risk and Data Analytics
Data Scientist, Insights - Online Recommendations
Senior Analyst, Global Quantitative Research
Atlanta, GA $87,000.00-$93,000.00 1 week ago
Senior Decision Scientist, Operations Research
Data Analyst - School of Medicine, Human Genetics
Graduate Intern - Optimization (Spring, 2025)
Advanced Analytics Analyst - Strategic Insights
Atlanta, GA $105,400.00-$124,000.00 10 hours ago
Data Scientist - Merchandising and Pricing
Johns Creek, GA $78,700.00-$131,100.00 1 week ago
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr