Clinical SAS Programming Lead

ClinChoice; Pasig; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

ClinChoice in Manila is seeking a senior clinical programmer to support FDA submissions. The role focuses on SDTM/ADaM data generation using SAS, creating tables, listings, and graphs for CSR, posters, and manuscripts. You will aid in ISS/ISE deliverables and define.xml packaging under GMP guidance.

Requires 4+ years of clinical programming with strong knowledge of ICH/GCP, and experience collaborating with global teams. Excellent problem-solving and mentoring abilities are essential.

Qualifications

• Bachelor’s or Master’s degree in Statistics, Mathematics, CS, EE, Biotechnology or related field with at least 4+ years of clinical programming experience.
• Proven knowledge in SAS, C/C++, Java, R, Python, MATLAB and SQL.
• Proficient in decoding programming logic and explaining to team members.
• Proficient in applying AI/ML concepts in practical scenarios.
• In-depth knowledge of ICH, GCP, clinical research and regulatory requirements.
• Strong communication and coordination with global teams.

Responsibilities

• Annotate Case Report Form 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 Statistical Analysis Plan.
• Create Tables, Listings, Graphs, Patient Profile for CSR, Posters, Manuscripts.
• Develop ADaM data, Tables, Listings, Figures for ISS/ISE.
• Create electronic submission packages to FDA (define.xml/define.pdf) with supervision.

Skills

SAS

C/C++

Java

Python

R

MATLAB

SQL

AI/ML

ICH/GCP

Data analysis

Education

Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related disciplines

Job description

ClinChoice in Manila is seeking a senior clinical programmer to support FDA submissions. The role focuses on SDTM/ADaM data generation using SAS, creating tables, listings, and graphs for CSR, posters, and manuscripts. You will aid in ISS/ISE deliverables and define.xml packaging under GMP guidance.

Requires 4+ years of clinical programming with strong knowledge of ICH/GCP, and experience collaborating with global teams. Excellent problem-solving and mentoring abilities are essential.