Clinchoice Inc.
Sr Statistical Programmer(REMOTE)
Fort Washington, PA, United States · Senior
Sponsorship not specifiedDetected 1961 days ago
PythonJavaC++MATLABMachine LearningData AnalysisStatisticsProject ManagementExcelElectrical EngineeringClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesSASResearchCommunicationMentoringMicrosoft OfficeBiostatisticsRegulatory Affairs
About the role
- ClinChoice is a clinical stage CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients.
- Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance.
- ClinChoice has established major delivery centers across US, China, Europe, India, Japan and the Philippines.
Responsibilities
- Develop SDTM specifications and generate SDTM datasets using SAS.
- Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
- Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
- Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
- Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
- Analyze information and develop innovative solutions to programming and data analysis challenges.
- Serve as a programming team lead and contribute to department initiative.
Requirements
- Bachelor's/Master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 3 years of clinical programming experience.
- In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
- Detail-oriented and ability to learn and adapt to changes.
Nice to have
- Proven knowledge and training in high level computing languages such as.
- SAS, C/C++, Java, R, Python, MATLAB and SQL.
- Database programming experience is a plus.
Benefits
- Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
Visa & Work Authorization
- pdf) following FDA/CDISC or sponsor guidelines
Apply directly at Clinchoice Inc. →Create a free account for alerts like thisView Clinchoice Inc. immigration profile
This listing is sourced directly from Clinchoice Inc.'s careers page and normalized into a canonical job model.