Senior Statistical Programmer Analyst II

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

Job Description:

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.