Senior Statistical Programmer / Analyst III

ClinChoice ANZ; Pasig; On-site; PHP 900,000 - 1,300,000; Full time

Job summary

ClinChoice ANZ is seeking a Senior Clinical Programmer to annotate Case Report Forms, develop SDTM/ADaM datasets in SAS and prepare submission packages in line with FDA guidelines.

The role involves leading programming efforts, mentoring team members, and coordinating with global sponsors to meet timelines while ensuring regulatory compliance and data integrity.

Qualifications

• Bachelor’s or Master’s degree in statistics/CS/related field with 5+ years of clinical programming.
• Proven knowledge in SAS, C/C++, Java, R, Python, MATLAB and SQL.
• Expert-level in decoding programming logic and assembling programming code.
• AI/ML concepts applied in real-world scenarios.
• In-depth knowledge of ICH, GCP, clinical research, clinical trial processes and regulatory requirements.
• Understanding of clinical drug development processes.
• Strong communication and coordination skills; ability to work with global teams.
• Detail-oriented and adaptable to changes.

Responsibilities

• Annotate Case Report Form and generate SDTM/ADaM datasets using SAS.
• Develop SDTM/ADaM specifications and datasets per SAP.
• Create Tables, Listings, Graphs and patient profiles for CSR, posters or manuscripts.
• Prepare submission-ready packages (definex/define.pdf) per FDA guidelines.
• Lead programming efforts and mentor team members.
• Coordinate with statisticians for inputs and interpretation.
• Ensure compliance with regulatory requirements in daily work.
• Collaborate with global teams to meet timelines and resources.

Skills

SAS

C/C++

Java

Python

R

MATLAB

SQL

AI/ML concepts

Communication skills

Clinical programming

Education

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

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 packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision.


• Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges;


• Serve as 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 initiatives.


• 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.


• Work with global team or sponsors to coordinate project deliverables, timelines and resources.

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 packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision.


• Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges;


• Serve as 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 initiatives.


• 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.


• Work with global team or sponsors to coordinate project deliverables, timelines and resources.

Skills And Responsibilities

• Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+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.


• Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.


• Expert level in applying concept in Artificial Intelligence and Machine Learning in 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 independently.


• In-depth understanding of clinical drug development process.


• Detail-oriented and ability to learn and adapt to changes.