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Clinical Data Analyst
3 weeks ago
We are continually seeking to streamline our operations, making it easier for us to collaborate with passionate problem solvers who innovate as a team to help our customers achieve their goals.
- Get to know our organization: Over the past five years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
- The following skills and qualifications are essential:
- Developing ADaM specifications and datasets for regulatory submissions using CDISC standards is critical.
- Producing high-quality Tables, Listings, and Figures (TFLs), covering both safety and efficacy endpoints, is key.
- Preparing Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for submission packages is required.
- SAS Programming: Advanced proficiency in Base SAS, SAS Macro, and SAS SQL for clinical trial data analysis and reporting is essential.
- Patient Narratives: Experience in programming patient narratives is highly valued.
- PK/PD Analysis: Background in Pharmacokinetics (PK) and Pharmacodynamics (PD) data analysis, including non-compartmental analysis and support for modeling activities, is preferred.
- Therapeutic Area Expertise: Preferred experience in Oncology, Neuroscience, and Immunology studies is an asset.
No matter what your role is, you'll take the initiative and challenge the status quo in a highly competitive and ever-changing environment.
