Hybrid Senior Manager, Statistical Programming Lead

NCBiotech

Raleigh (NC)

Hybrid

USD 146,000 - 189,000

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

Gilead Sciences Inc. is seeking a Sr Manager, Statistical Programming to join our team in a hybrid role at Raleigh, NC or Foster City, CA. You will oversee programming for study reports and integrated summaries supporting regulatory and scientific objectives.

The role requires extensive SAS programming, CDISC standards, and strong collaboration with Clinical Development. Experience with FDA/global submissions is highly preferred.

Qualifications

BS/MS/PhD in Biostatistics/Computer Science or equivalent with pharma/biotech experience.
8+ years (BS) or 4+ years (MS) or 2+ years (PhD) in pharma/biotech.
Strong SAS programming and regulatory submission experience (NDA/BLA/MAA).
Deep knowledge of CDISC standards and statistical programming processes.

Responsibilities

Collaborate with Clinical Development to meet project deliverables and timelines.
Produce programming deliverables (tables, figures, listings) for reports and submissions.
Direct design or coding of analysis datasets and outputs.
Ensure documentation complies with departmental procedures and standards.
Interact with other departments to deliver user-defined statistical reports.
Support regulatory submissions and post-filing activities.

Skills

SAS

Biostatistics

Statistics

Regulatory knowledge

Clinical trials design

ICH/GCP

Programming leadership

Data analysis

Education

BS in Biostatistics/Computer Science

MS in Biostatistics/Computer Science

PhD in Biostatistics/Computer Science

Tools

SAS

CDISC (CDASH, SDTM, ADaM)

Job description

The role requires extensive SAS programming, CDISC standards, and strong collaboration with Clinical Development. Experience with FDA/global submissions is highly preferred.

Get your free, confidential resume review.

or drag and drop your file here.