Ecocareers ยท 3 months ago
Clinical SAS Programmer
Omaha, NE
Full-time
Onsite
Mid, Senior Level
3+ years expConfidential company is seeking a Clinical SAS Programmer to design and code SAS programs for clinical projects. The role involves producing regulatory compliant datasets, performing quality control checks, and providing programming support for clinical trials.
Staffing & Recruiting
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 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 eCRF, SDTM and ADaM datasets specifications for datasets programming
Provides programming support for adhoc analysis
Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
Manages timelines and schedules of specific phases of projects with internal personnel and external vendors
Acts as lead programmer for a study
Reviews or validates statistical deliverables of vendors for assigned project(s)
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
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase