Vaxcyte · 1 day ago
Senior Manager, Clinical Programmer
United States
Full-time
Remote
Senior Level, Lead/Staff
$161K/yr - $188K/yr
8+ years expVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. The Senior Manager, Clinical Programmer will lead and deliver high-quality programming solutions for clinical trials and regulatory submissions, requiring strong technical expertise and collaboration across multiple functions.
BiopharmaBiotechnologyHealth Care
Responsibilities
Statistical Analysis Execution: Independently develop, validate, and maintain complex programs and utilities to generate tables, listings, and figures (TLFs) for clinical study reports in accordance with the Statistical Analysis Plan
Regulatory Submission Deliverables: Develop, review, and validate CDISC-compliant e-submission components, including:
Annotated CRF (acrf.pdf)
SDTM specifications and datasets
ADaM specifications and datasets
Xml or define.pdf
Study Data Reviewer’s Guide (cSDRG.pdf)
Analysis Data Reviewer’s Guide (ADRG.pdf)
Collaboration: Partner with statisticians to finalize mock tables and ensure alignment with analysis requirements
Vendor Management: Oversee programming vendors to ensure quality deliverables, adherence to timelines, and complete project documentation
Cross-Functional Support:
Work with Data Management to resolve data issues
Collaborate with Clinical Operations to integrate data from multiple sources
Coordinate with Clinical/Regulatory Writing to standardize output and processes for various submissions
Ad Hoc Analysis: Perform analyses for internal or regulatory requests under statistical guidance
Integrated Submissions: Compile data across studies for ISS/ISE and related electronic submission deliverables
Process Improvement: Drive standardization of programming rules and support visualization capabilities for enhanced reporting
Qualification
Required
Bachelor's degree in Computer Science, Statistics, or related discipline with minimum 8 years experience in clinical programming and minimum 3 years in vaccine clinical studies with BLA e-submission experience
Proficient in SAS
Strong knowledge of CDISC standards (SDTM, ADaM) and FDA OVRR guidance
Familiarity with ICH, GCP, clinical research processes, and regulatory requirements
Detail-oriented with excellent problem-solving abilities
Strong communication and coordination skills
Ability to manage multiple priorities and vendors effectively
Preferred
Experience with R or Python is a plus
Benefits
Comprehensive benefits
Equity component
Company
Vaxcyte
Vaxcyte focuses on developing vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide.
201-500 employees
H1B Sponsorship
Vaxcyte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (7)
2023 (5)
2022 (7)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$3.85BKey Investors
CARB-XTPG GrowthAbingworth
2024-09-04Post Ipo Equity· $1.5B
2024-01-30Post Ipo Equity· $862.5M
2023-04-19Post Ipo Equity· $500M
Leadership Team
Andrew Guggenhime
President & Chief Financial Officer
Jeff Fairman
Founder and Vice President, Research
Recent News
2025-12-09
Company data provided by crunchbase