Katalyst CRO ยท 3 months ago
Statistical Programmer
Cincinnati, OH
Contract
Onsite
Entry, Mid LevelKatalyst CRO is a company focused on clinical research, and they are seeking a Statistical Programmer to develop SAS programs and statistical outputs for clinical trial data management. The role involves ensuring the quality of statistical outputs, contributing to regulatory submissions, and supporting data visualization and analysis for trial results.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop SAS programs and statistical output for the management and reporting of clinical trial data managed by GCD
Guarantee quality of statistical output produced by external provider, to program tools to support data review activities and data visualization, to collaborate on the interpretation and communication of trial results
Contribute to regulatory submissions, converting data according to regulatory requirements, preparing integrated analyses and related documentation
Perform post-hoc analysis for exploratory purposes, or to support regulatory requests, to prepare analysis for paper publications
Support the development of standard operating procedures
To convert data to CDISC SDTM, following project specifications
Develop SAS programs to generate analysis datasets (CDISC compliant)
Produce datasets documentation according to CDISC and FDA requirements (define.xml) and/or to review analysis datasets documentation prepared by providers
Develop SAS programs to produce tables, listings, and figures as planned in the statistical analysis plan and to support data review activity before database lock
Develop SAS macros and SAS programs for data quality evaluation and to develop data quality reports
Writing, documenting, and performing quality control review of SAS programs
Perform ad hoc analysis for various statisticians' requirements
Support statisticians in the preparation and/or review and QC of statistical package for FDA submissions
Perform QC of the programming material prepared by external providers guaranteeing the output provided is correct and in line with International requirements and with internal SOP/Standards
Qualification
Required
Bachelor's degree or higher, preferably in a scientific discipline such as Statistics, Mathematics, Computer Science, or a related applicable field
Good experience in SAS
Proficient in Macro Facility
Extensively involved in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to Standard Operating Procedures (SOPs)
Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM), Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification (Define.xml)
General knowledge of statistical methods
Have excellent analytical, problem solving, communication and interpersonal skills
Effective verbal and written communication skills
Strong commitment to quality
Ability to work in a team-based environment
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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