Data Analyst
3 days ago
As a Biostatistician II, you will be responsible for developing and implementing statistical methods to analyze clinical trial data.
- Design and implement statistical analysis plans to meet regulatory requirements
- Develop and maintain ADaM specifications and datasets for regulatory submissions
- Produce high-quality tables, listings, and figures (TFLs) covering both safety and efficacy endpoints
- Prepare Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for submission packages
- Support pharmacokinetics (PK) and pharmacodynamics (PD) data analysis, including non-compartmental analysis and modeling activities
Requirements:
Essential Skills and Qualifications:
- Advanced proficiency in Base SAS, SAS Macro, and SAS SQL
- Hands-on experience with CDISC standards and ADaM dataset development
- Strong ability to produce TFLs and ISS/ISE packages
- Background in PK/PD data analysis
- Preferred experience in Oncology, Neuroscience, and Immunology studies
Benefits:
We offer:
- Opportunities for career growth and professional development
- A supportive and collaborative work environment
- Competitive compensation and benefits package
Additional Information:
While we appreciate the interest of all applicants, please note that only qualified candidates will be considered. The company reserves the right to modify or change job responsibilities at any time.
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