Senior Manager, Clinical Programmer

Vaxcyte

4d•$161,000 - $188,000•Remote

About The Position

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. We are seeking an experienced Sr. Manager, Clinical Programmer, to lead and deliver high-quality programming solutions for clinical trials and regulatory submissions. This role requires strong technical expertise, leadership skills, and the ability to collaborate across multiple functions to ensure timely and compliant deliverables.

Requirements

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. Other combinations of education and/or experience may be considered.
Proficient in SAS; experience with R or Python is a plus
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

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.