Principal, Statistical Programmer

Overview

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Principal, Statistical Programmer? The job is in our King of Prussia, PA or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will be a member of the Biostatistics team and plays a lead role in performing all statistical programming tasks required for clinical trial analysis and reporting.

• Provide statistical programming expertise in statistical programming deliverables, including data processing, CDISC compliance, regulatory submission and SAS coding.
• Help function director manage resources, timelines, and assignments for a single or multiple clinical trials assigned to him/her. Estimate resource needs. Work closely with the function director on resource allocation, timeline consolidation and implementation.
• Oversee the work of statistical programming services provided by vendors to achieve quality, timely, and cost-effective study deliverables. Act as the primary point of contact on all statistical programming matters with external vendors that provide statistical programming services to Seqirus.
• Mentor junior programmers for their statistical programming activities. Provide technical support and mentoring to junior programmers.
• Support development and maintenance of the Seqirus statistical programming relevant standards, SOPs/WI and guidance.
• Perform statistical programming on various tasks for clinical data analysis needs, including but not limited to generating Study Data Standardization Plan (SDSP), SDTM data/ADaM data specifications, CRF annotation for SDTM, define.xml, reviewers guide, system and study level macros, tables, listings and figures, regulatory e-submission components.
• As a SME, establish and implement programming standards and comply with regulatory requirements among project team members and across all studies. Develop standard macros and/or tools for the statistical programming platform for data analysis and reporting. Ensure that statistical programs developed for specific protocols are effectively portable to other protocols (Reusable code).

• Bachelor's Degree life science, computer programming, statistics etc.
• 5+ years of experience in scientific programming/simulations
• Expertise in R or Python, and knowledge of SAS
• Knowledge of GIT, or similar version control system
• Experience in working with larger data sets (>1m records)
• Ability to understand statistical issues, extract specifications, and convert into working simulation code