Senior Statistical Programmer Lead - SDTM/ADaM & Submissions

ClinChoice; Pasig; Sur place; PHP 900 000 - 1 100 000; Plein temps

Résumé du poste

ClinChoice in the Philippines seeks an experienced Clinical Programmer to annotate CRFs, develop SDTM/ADaM datasets, and generate Tables, Listings and Graphs for CSR and manuscripts. You will contribute to eSubmission packages to FDA and collaborate with global statisticians.

The role requires 4+ years in clinical programming, strong SAS skills, and knowledge of ICH/GCP. A team-lead mindset and ability to mentor colleagues are valued assets.

Qualifications

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related disciplines.
• 4+ years of clinical programming experience with SAS or other programming languages.
• Knowledge of ICH/GCP and regulatory guidelines for clinical data.
• Ability to communicate with global teams and deliver under supervision.

Responsabilités

• Annotate Case Report Forms 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 SAP.
• Create tables, listings, graphs, and patient profiles for CSR, posters, and manuscripts.
• Produce ADaM data, tables, listings, and figures for ISS/ISE.
• Prepare eSubmission packages (e.g., define.xml) per FDA guidelines with minimal supervision.
• Provide programming guidance and mentoring to team members.
• Review deliverables for quality and consistency.

Connaissances

SAS

C/C++

Java

R

Python

MATLAB

SQL

AI/ML

Formation

Bachelor’s/Master’s in Statistics or related

Outils

SAS

R

Python

SQL

Description du poste

ClinChoice in the Philippines seeks an experienced Clinical Programmer to annotate CRFs, develop SDTM/ADaM datasets, and generate Tables, Listings and Graphs for CSR and manuscripts. You will contribute to eSubmission packages to FDA and collaborate with global statisticians.

The role requires 4+ years in clinical programming, strong SAS skills, and knowledge of ICH/GCP. A team-lead mindset and ability to mentor colleagues are valued assets.