The Statistical Programmer II
14 hours ago
We're seeking for a Statistical Programmer II to join our growing clinical programming team. The ideal candidate will have solid SAS programming skills, a strong understanding of CDISC standards, and experience working on global clinical studies. This is an excellent opportunity to contribute to meaningful clinical research in a collaborative and innovative environment.
Key Responsibilities:
- Program all tables, listings, and graphs (TLGs) necessary for assigned clinical study reports (CSRs).
- Develop customized data displays (listings, summary tables, and graphics) according to the Statistical Analysis Plan (SAP) and shell displays.
- Write code using Base SAS programs, SAS procedures, or standardized macros.
- Work with Oncology RECIST guidelines and Leukemia studies (preferred).
- Follow CDISC structures for ADaMs and SDTMs, and ICH GCP guidelines.
- Support ISS and ISE studies.
- Create and manage SAS datasets for clinical data, including safety (ADSL, ADAE, ADLB, ADEX, ADVS, ADEG) and efficacy datasets (ADRS, ADEFF, ADTTE).
- Develop project-specific macros and formats.
- Identify and resolve data issues in collaboration with Data Management and Statistics teams.
- Prepare documentation describing datasets, derived variables, and project metadata.
- Collaborate with US time zones to support team activities and sponsor meetings.
- Provide guidance and on-the-job training to junior programmers.
- Track project timelines, deliverables, and communicate risks or issues to clients.
Qualifications:
- Bachelor's degree required; Master's degree in Biostatistics, Computer Science, Mathematics, Pharmaceutical Science, or related field preferred.
- At least 5 years of clinical or SAS programming experience.
- Strong SAS programming skills (SAS Base Certified required; Advanced Certification preferred).
- Experience with CDISC ADaM and SDTM standards.
- Excellent communication skills in English (written and verbal).
- Ability to manage multiple projects and meet deadlines.
- Strong analytical skills, attention to detail, and ability to work independently or in a team.
- Experience with Oncology and safety/efficacy datasets is a strong advantage.
Work Environment & Benefits:
- Hybrid work setup (3 days onsite in Taguig, 2 days WFH).
- Collaborative and supportive team culture.
- Opportunities for career growth and training.
- Exposure to global clinical research projects.
- Minimal travel (up to 5%)
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