Senior Statistical Programmer / Analyst III

32 minutes ago
Senior
Data Science and Analytics
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

Description

  • Annotate Case Report Forms (acrf.pdf) according to 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 to support 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, with no supervision.
  • Serve as a point of contact for programming with statisticians on statistical input and analysis interpretation.
  • Lead the programming team and contribute to department initiatives.
  • Provide guidance, mentoring, and training to team members and help resolve issues from cross-functional teams.
  • Review draft and final production deliverables to ensure quality and consistency.
  • Coordinate project deliverables, timelines, and resources with global teams or sponsors.
  • Analyze programming and data issues and develop innovative solutions to challenges.

Requirements

  • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or a related scientific discipline.
  • 5+ years of clinical programming experience.
  • Proven knowledge of SAS, C/C++, Java, R, Python, MATLAB, and SQL.
  • Database programming experience is a plus.
  • Expert-level ability to decode programming logic and assemble code from provided logic.
  • Expert-level application of 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.
  • Strong communication and coordination skills, with the ability to communicate independently with global teams.
  • Good understanding of the clinical drug development process.
  • Detail-oriented with the ability to learn and adapt to changes.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Lead Data Scientist, AdTech

Launch Potato 51-250 Professional Services

Launch Potato is hiring a Senior Applied Data Scientist to own end-to-end modeling for a priority vertical focused on driving ROAS, revenue, and media efficiency across its digital media portfolio.

AWS Deep Learning Digital Marketing Facebook Ads Google Ads LLM Looker Machine Learning Python Reinforcement Learning SQL
2 minutes ago

Lead Data Scientist, AdTech

Launch Potato 51-250 Professional Services

Launch Potato is hiring a Senior Applied Data Science professional to own end-to-end modeling for a priority revenue vertical, starting with insurance and advertiser quality, with the goal of improving ROAS and media efficiency.

AWS Deep Learning Digital Marketing Facebook Ads Google Ads LLM Looker Machine Learning Python Reinforcement Learning SQL
17 minutes ago

Senior Data Science Manager, User Growth

Duolingo 251-1K Diversified Consumer Services

Duolingo is hiring a Senior Data Science Manager to lead the Growth pillar’s data science function, guiding analytics for user growth decisions across a rapidly scaling product and business.

Machine Learning Python R SQL Statistics
17 minutes ago

Lead Applied Scientist, Marketing

Launch Potato 51-250 Professional Services

Launch Potato is hiring a Senior Applied Data Scientist to own end-to-end modeling for priority growth verticals, starting with Insurance and Advertiser Quality, with the goal of improving ROAS and revenue performance.

AWS Deep Learning Digital Marketing Facebook Ads Google Ads LLM Looker Machine Learning Python Reinforcement Learning SQL
17 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers