Gan & Lee Pharmaceuticals
Clinical Programmer
Remote - Full Time
Summary
This position is responsible for leading statistical programming activities to support clinical development projects, regulatory submissions, and lifecycle management of biopharmaceutical products. This role ensures the accuracy, integrity, and compliance of clinical data analysis through advanced programming expertise and cross-functional collaboration. This position reports directly to the Senior Director and Head of Biometrics.
Education and Experience
Skills and Qualifications
This position is responsible for leading statistical programming activities to support clinical development projects, regulatory submissions, and lifecycle management of biopharmaceutical products. This role ensures the accuracy, integrity, and compliance of clinical data analysis through advanced programming expertise and cross-functional collaboration. This position reports directly to the Senior Director and Head of Biometrics.
Education and Experience
- MS in Computer Science/Biostatistics/Statistics or related field
- 5+ years of experience in statistical programming within the biotechnology, pharmaceutical, or clinical research industry.
- Proven experience managing multiple projects simultaneously.
- Experience in therapeutic areas such as diabetes, obesity or metabolic disease is highly desirable.
- Prior experience in regulatory interactions (e.g., FDA, EMA) and submissions is required
Skills and Qualifications
- Advanced proficiency in SAS. Other statistical programming languages such as R and Python are desirable.
- In-depth knowledge of CDISC standards (SDTM, ADaM) and clinical data structures.
- Familiarity with clinical trial design, data integration, and electronic submission requirements (e.g., eCTD).
- Thorough understanding of global regulatory guidelines (e.g., ICH-GCP, FDA/EMA regulations) and industry best practices.
- Capable of developing innovative programming solutions to address complex data challenges.
- Highly effective written, oral, and interpersonal communication skills as well as ability to work in interdisciplinary contexts outside statistics.
- Lead the development and validation of datasets, tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions.
- Oversee the implementation of CDISC standards and ensure programming alignment with statistical analysis plans (SAPs).
- Contribute to the preparation of integrated summaries of efficacy/safety (ISE/ISS) and other submission documents.
- Address statistical programming inquiries from health authorities and external partners.
- Work closely with biostatisticians to optimize data analysis strategies and ensure accurate interpretation of results.
- Coordinate with data management function to validate data quality and resolve discrepancies.
- Develop and implement programming standards, tools, and SOPs to enhance efficiency and compliance.
- Ensure all programming activities adhere to regulatory requirements and company quality standards.
