Hybrid Senior Statistical Programming Lead

Biopharma Careers; San Francisco (CA); Hybrid; USD 146,000 - 219,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Benefits package

Job summary

Gilead Sciences Inc. in Foster City, CA or Raleigh, NC seeks a Sr Manager, Statistical Programming to lead the programming work for study reports and integrated summaries in support of regulatory, scientific and business objectives.

This hybrid role requires collaboration with Clinical Development, generating tables, figures and listings, and ensuring quality and regulatory compliance for FDA and global submissions.

Qualifications

• BS in Biostatistics/Computer Science or equivalent with 8+ years in pharma/biotech.
• MS in Biostatistics/CS or equivalent with 4+ years in pharma/biotech.
• PhD in Biostatistics/CS or equivalent with 2+ years in pharma/biotech.

Responsibilities

• Collaborate with Clinical Development to meet study deliverables.
• Oversee programming deliverables for study reports and integrated summaries.
• Direct design and coding of analysis files.
• Ensure documentation aligns with departmental procedures.
• Provide primary and secondary programming support.
• Support strategic initiatives and regulatory submissions.

Skills

SAS Macros

CDISC standards

Clinical programming

Regulatory submissions

Education

BS in Biostatistics/Computer Science

MS in Biostatistics/CS

PhD in Biostatistics/CS

Tools

SAS Software

CDISC SDTM/ADaM

Clinical Data Management Systems

Job description

Gilead Sciences Inc. in Foster City, CA or Raleigh, NC seeks a Sr Manager, Statistical Programming to lead the programming work for study reports and integrated summaries in support of regulatory, scientific and business objectives.

This hybrid role requires collaboration with Clinical Development, generating tables, figures and listings, and ensuring quality and regulatory compliance for FDA and global submissions.