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Senior Statistical Programmer/Analyst

2 hours, 35 minutes ago
Philippines
Senior
Data Scientist
Data Science and Analytics
Java Machine Learning MATLAB Python R SQL
Apply Now
ClinChoice

ClinChoice

ClinChoice is a leading full-service contract research organization (CRO) that provides high-quality solutions to clients in the pharmaceutical, biotechnology, medical device, and consumer products sectors, focusing on accelerating the development and ...

Professional Services
1K-5K
Founded 1995
View All Jobs 4

Description

  • Annotate Case Report Forms (acrf.pdf) following FDA/CDISC or sponsor guidelines.
  • Develop SDTM specifications and generate SDTM datasets using SAS.
  • Develop ADaM specifications and generate ADaM datasets using SAS based on the Statistical Analysis Plan.
  • Develop Tables, Listings, Graphs, and Patient Profiles in support of Clinical Study Reports, posters, and manuscripts.
  • Develop ADaM data, Tables, Listings, and Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
  • Create electronic submission packages for the FDA, including define.xml or define.pdf, following FDA guidelines.
  • Analyze programming and data challenges and develop innovative solutions.
  • Support statisticians as the programming point of contact for statistical input and interpretation.
  • Serve as a programming team lead and contribute to department initiatives.
  • Provide guidance, mentoring, and training to team members and help resolve cross-functional issues.
  • Review draft and final deliverables to ensure quality and consistency.
  • Coordinate project deliverables, timelines, and resources with global teams or sponsors.

Requirements

  • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or a related scientific discipline.
  • At least 4+ years of clinical programming experience.
  • Proven knowledge of high-level computing languages including SAS, C/C++, Java, R, Python, MATLAB, and SQL.
  • Database programming experience is a plus.
  • Ability to decode programming logic, assemble code from provided logic, and explain it to team members.
  • Proficiency in applying Artificial Intelligence and Machine Learning concepts in real-world settings.
  • In-depth knowledge of ICH, Good Clinical Practices, clinical research, clinical trial processes, and related regulatory requirements and terminology.
  • Good understanding of the clinical drug development process.
  • Strong communication and coordination skills, including the ability to communicate with global teams.
  • Detail-oriented with the ability to learn and adapt to change.
  • Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.

Interested in this position?

Apply directly on the company website

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