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Senior Manager, Clinical Programmer

US - Remote

Join our Mission to Protect Humankind!

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. 
 
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
 
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
 
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
 
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
 
*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

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.

Essential Functions:

You will play a critical role in clinical data programming and submission activities. Responsibilities include, but are not limited to:

  • 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.

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
Reports to: Executive Director, Clinical Biostatistics
 
Location: US - Remote
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $161,000 – $188,000 (SF Bay Area). Salary ranges for non-California locations may vary.
 
Relocation: 
This role is not eligible for relocation assistance. 
 
#LI-JN1

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

 

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