Katalyst CRO ยท 5 months ago
Clinical SAS Programmer
NJ-444, Newark, NJ, USA
Full-time
Onsite
Mid Level
3+ years expKatalyst CRO is a company focused on contract research in Clinical trials of drugs, biologics, and medical devices. They are seeking a Clinical SAS Programmer who will design and code SAS programs for clinical projects, ensuring compliance with regulatory standards and producing high-quality datasets and reports.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)
Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets
Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements
Provides input in the design and development of case report forms and clinical databases
Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs
Programs for quality checks for clinical study raw data and report the findings to Data Management
Provides input in the design and development of case report forms and clinical study databases
Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming
Qualification
Required
MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years
Experience in providing statistical programming support to early and late phase clinical trials
Excellent skills in SAS programming and statistical reporting
Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements
Familiarity with FDA and ICH regulations and guidelines
Excellent problem-solving skills
Good written and verbal communication skills and organizational and documentation skills
Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc
Ability to prioritize and multi-task effectively
Demonstrated positive attitude and the ability to work well with others
Company
Katalyst CRO
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.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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