Senior Biostatistical SAS Programmer
4 weeks ago
We are seeking a Senior Biostatistical SAS Programmer with 7 years of experience in the pharmaceutical or biologics industry. The ideal candidate will have expertise in biological applications (e-bia), New Drug Applications (NDAs), and in-depth knowledge of FDA regulatory guidelines, particularly items 10 and 11.
Key Responsibilities:
- Utilize SAS (version 8.2 or higher) to develop and execute code for generating tables, listings, and NDA figures.
- Apply Proc Report, SAS Graphics, and SAS/STAT to produce high-quality statistical reports and visualizations.
- Write new SAS code as needed to support regulatory submissions (CTD/eCTD).
- Collaborate in a team environment to meet project deadlines and objectives.
Requirements:
- Minimum of 7 years of experience in the pharma or biologics industry.
- Proven experience with biological applications (e-bia) and NDA processes.
- Extensive knowledge of FDA regulatory requirements, especially items 10 and 11.
- Proficient in SAS version 8.2 or higher, including Proc Report, SAS Graphics, and SAS/STAT.
- Strong ability to write and execute SAS code for data analysis and reporting.
- Master's degree in Biostatistics, Computer Science, or related field.
Preferred Skills:
- Experience in CTD/eCTD regulatory submissions.
- Ability to thrive in a collaborative team setting.
Thank You
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