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