Senior Statistical Programmer / Analyst III at ClinChoice

Pasig, Metro Manila, Philippines -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SAS, C/C++, Java, R, Python, MATLAB, SQL, Artificial Intelligence, Machine Learning, Clinical Research, Good Clinical Practices, Statistical Analysis, Data Analysis, Programming Logic, Communication Skills, Detail-oriented

Industry

Pharmaceutical Manufacturing

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. 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.

Responsibilities

The role involves annotating case report forms, developing SDTM and ADaM specifications, and generating datasets using SAS. Additionally, the programmer will create electronic submission packages and serve as a point of contact for statistical input and analysis interpretation.