Katalyst CRO
Posted 19 days agoVerified live 2d ago
Clinical Database Programmer
Brief overview
Remote
UndergradOr in progress
4+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
SDTM programmingElluminateSQL programmingSAS programmingICH/GCP guidelines21 CFR Part 11Clinical trial methodologiesCDISC SDTM data modelCDISC ADaM data modelWHODrug medical coding dictionaryMedDRA medical coding dictionary
About the company
Katalyst CROkatalysthls.com
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
Visa sponsorship history
4 years sponsoring, last filed FY2026
Data powered by U.S. Department of Labor. This does not guarantee sponsorship for this specific role.32H-1B approved
89%approval rate
3new H-1B hires
9PERM certified
$240,000median wage / yr
H-1B Petition ApprovalsVisas USCIS actually granted: the strongest sign the company sponsors.
202319
20249
20254
LCA Certified ApplicationsAn early filing step, not a visa approval: it signals intent, not confirmed sponsorship.
20236
20242
20259
20262
Green Card (PERM) FilingsCertified green card filings: a long-term commitment to international hires.
20235
20241
20253
Top sponsored roles
VALIDATION ENGINEERQUALITY ENGINEERCLINICAL DATA ANALYSTPRODUCT DEVELOPMENT ENGINEERCLINICAL DATA MANAGER
Sponsored employees from
India
Job description
Summary
Katalyst CRO is seeking a Clinical Database Programmer to join their Data Sciences group. The role focuses on SDTM programming and the development and maintenance of SDTM datasets for clinical studies, utilizing tools like SAS and elluminate.
Responsibilities
- Annotate CRFs in accordance with CDISC published or program specific guidelines
- Craft SDTM dataset specifications
- Program and validate SDTM datasets in SAS and/or elluminate
- Participate in the quality assurance of vendor developed SDTM datasets and documentation
- Participate in the review of eCRFs and collection tools
- Participate in the review of data transfer specifications as it relates to data flow for the study
- Liaise with study team members and develop custom objects in elluminate
- Utilize the Mapper module and T-SQL programming to develop custom datasets
- Develop at least a subset of SDTM datasets within elluminate
- Ensure documentation and validation of objects are timely and complete
- Participate in the testing of elluminate upgrades and documenting test scripts
- Ensures data standardization and maintains Ironwood data model across studies
- Contributes to quality system requirements for clinical data programming ( e.g., review and/or develop SOPs)
- Promotes enduring relationships regarding datasets and data transfers with study team members, CROs, third party data vendors, and EDC vendors
- Maintains current knowledge of and ensures all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory, GxP requirements and related policies and procedures. Advocates for full legal compliance and ethical conduct in all business transactions
- Duties, responsibilities, and activities may change, or new ones may be assigned as business and organizational requirements evolve
Skills
- 4+ years of experience in SDTM programming
- Experience with elluminate or a dynamic visualization tool
- Proven SQL & SAS programming experience
- Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
- Experience with CDISC® related data models like SDTM, and ADAM
- Knowledge of medical coding dictionaries (WHODrug, MedDRA)
- Ability and willingness to learn new technologies
- Excellent team player with strong verbal and written communication skills
- Associate's degree or higher in information systems, science or related discipline
Qualifications
Must Haves
- 4+ years of experience in SDTM programming
- Experience with elluminate or a dynamic visualization tool
- Proven SQL & SAS programming experience
- Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
- Experience with CDISC® related data models like SDTM, and ADAM
- Knowledge of medical coding dictionaries (WHODrug, MedDRA)
- Ability and willingness to learn new technologies
- Excellent team player with strong verbal and written communication skills
- Associate's degree or higher in information systems, science or related discipline
