Clinchoice Inc.

Clinchoice Inc.

Sr Statistical Programmer(REMOTE)

Fort Washington, PA, United States · Senior

Sponsorship not specifiedDetected 2052 days ago
PythonJavaC++CMATLABMachine LearningData AnalysisStatisticsProject ManagementExcelElectrical EngineeringClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesSASResearchCommunicationMentoringMicrosoft OfficeBiostatisticsRegulatory Affairs

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odds of building a lasting career here

40Risky
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

This may be a green-card test advertisement

This posting's live window overlaps a recruitment period this employer reported to the Department of Labor for Statisticians in Horsham, PA (2024-08-01 to 2024-08-26). Green-card labor certification requires publicly advertising a role that is often already committed to a specific employee, and that filing states the worker already held the job.DOL case G-100-24336-508399 · Certified

Green-card follow-through: 90%

Of 10 labor certifications old enough to have been used, 1 expired without the employer filing the next step. Median time from filing to decision: 490 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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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
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This listing is sourced directly from Clinchoice Inc.'s careers page and normalized into a canonical job model.