ClinChoice

Global CRO providing full-service clinical development

Senior Statistical Programmer / Analyst 2

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours

Full-timePasig, Metro Manila, PhilippinesNo salary listedIn-person

About the Job

Requirements

A bachelor's or master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or a related scientific discipline is required.
At least four years of clinical programming experience is required, along with at least one year of project management experience and one year of people management experience.
Knowledge and training in high-level computing languages such as SAS, C/C++, Java, R, Python, MATLAB, and SQL are required.
Ability to decode programming logic, assemble code based on provided logic, and explain it to team members is required.
Ability to apply artificial intelligence and machine learning concepts in real-world settings is required.
In-depth knowledge of ICH, Good Clinical Practices, clinical research, the clinical trial process, and related regulatory requirements and terminology is required.
A good understanding of the clinical drug development process is required.
Ability to communicate and coordinate with global teams with supervision is required.
Attention to detail and ability to learn and adapt to changes are required.

Responsibilities

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 in support of 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, such as define.xml or define.pdf, following FDA guidelines with minimum supervision.
Analyze information and develop innovative solutions to programming and data analysis challenges.
Serve as the programming point of contact with statisticians for statistical input and interpretation of analyses.
Follow and reinforce regulatory agency requirements in daily work.
Serve as a programming team lead and contribute to department initiatives.
Guide, mentor, and train team members, and help resolve issues raised by cross-functional teams.
Review draft and final production deliverables for project quality and consistency.

Desired Qualifications

Database programming experience is a plus.

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.
Minimum of 4+ years of clinical programming experience, along with 1+ year of project management and 1+ year of people management 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.

About the Company

ClinChoice

Global CRO providing full-service clinical development

ClinChoice is a global contract research organization (CRO) that provides outsourced clinical development services across the full lifecycle for pharmaceutical, biotechnology, medical device, and consumer health customers. It delivers services such as clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance to support trials from early development through post-approval. The company differentiates itself with a large, global workforce—over 4,000 professionals in more than 30 countries—and growth through mergers and acquisitions, enabling multinational trial execution. Its goal is to help clients accelerate approvals and navigate complex regulatory environments by offering flexible project-based and FSP engagement models for end-to-end development and lifecycle support.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Whitemarsh Township, Pennsylvania
Founded: 1995

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