Deskripsi Pekerjaan
We are seeking a highly skilled and experienced Senior Statistical Programmer to join our dynamic team in Taguig City. In this pivotal role, you will leverage your extensive expertise in statistical programming to design and implement robust methodologies that drive the success of our clinical trials. You will be responsible for delivering high-quality statistical output, tables, figures, and listings (TFLs) that meet the rigorous demands of both internal stakeholders and external regulatory bodies.
This is a unique opportunity to work within a global leader in life sciences, contributing to the development of therapies that improve patient outcomes. You will collaborate closely with cross-functional teams including Clinical Operations, Data Management, and Medical Writing to ensure data integrity and accuracy. If you are passionate about data analysis and want to make a tangible impact in the pharmaceutical industry, we want to hear from you.
Tanggung Jawab
- Develop and implement comprehensive statistical programming methodologies and analysis plans (SAPs) for Phase I-IV clinical trials.
- Generate and validate high-quality statistical output, including tables, figures, and listings (TFLs) for clinical study reports.
- Perform complex data cleaning, validation, and statistical analysis using SAS, R, or SQL.
- Maintain and update programming specifications and documentation to ensure regulatory compliance.
- Collaborate effectively with cross-functional teams to troubleshoot data issues and support data management activities.
- Mentor junior programmers and provide technical guidance to enhance team capabilities.
- Ensure all deliverables adhere to Good Clinical Practice (GCP) and internal quality standards.
Kualifikasi
- Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative field.
- Minimum of 5-7 years of professional experience in statistical programming within the pharmaceutical or biotechnology industry.
- Advanced proficiency in SAS (Base, MACROS, Graph) or R programming languages.
- Strong knowledge of clinical trial design, regulatory guidelines (e.g., ICH-GCP, FDA), and SDTM/ADaM implementation.
- Excellent problem-solving skills and the ability to manage multiple priorities in a fast-paced environment.
- Strong communication skills, both written and verbal, with the ability to present complex statistical concepts clearly.