Senior Statistical Programmer / Analyst II

ClinChoice; Pasig; Sur place; PHP 600 000 - 1 000 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

SAS

C/C++

Java

Python

R

MATLAB

SQL

AI/ML

ICH/GCP

Data analysis

Formation

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

Description du poste

• Annotate Case Report Form (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 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.
• Proficient in analyze information and develop innovative solutions to programming and data analysis challenges;
• Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation
• Follow and reinforce regulatory agency requirements during daily job.
• Serve as a programming team lead and contribute to department initiative.
• Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
• Review draft and final production deliverables for project to ensure quality and consistency.

Responsibilities

• Annotate Case Report Form (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 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.
• Proficient in analyze information and develop innovative solutions to programming and data analysis challenges;
• Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation
• Follow and reinforce regulatory agency requirements during daily job.
• Serve as a programming team lead and contribute to department initiative.
• Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
• Review draft and final production deliverables for project to ensure quality and consistency.

Skills and Qualifications

• Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 4+ years of clinical programming experience.
• 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.
• Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
• Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
• In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Good understanding of clinical drug development process.
• Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
• Good understanding of clinical drug development process.
• Detail-oriented and ability to learn and adapt to changes.