CSL · 7 hours ago
Principal, Statistical Programmer
Greater Philadelphia
Full-time
Hybrid
Senior Level, Lead/Staff
5+ years expCSL's R&D organization is focused on accelerating innovation to deliver impactful therapies for patients. The Principal, Statistical Programmer will lead statistical programming tasks for clinical trial analysis and reporting, ensuring compliance with standards and providing technical expertise for regulatory submissions.
BiotechnologyHealth CareHealth DiagnosticsMedical
Hiring Manager
Jamie O'Malley
Responsibilities
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)
Qualification
Required
Bachelor's Degree in life science, computer programming, statistics, etc
5+ years of experience in scientific programming/simulations
Expertise in R or Python
Knowledge of SAS
Knowledge of GIT, or similar version control system
Experience in working with larger data sets (>1 million records)
Ability to understand statistical issues, extract specifications, and convert into working simulation code
Company
CSL
CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$111M2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO
Leadership Team
Jeffrey Ball
Chief Sustainability Officer
Joy Linton
Strategic Advisor
Recent News
Pharma Letter
2026-01-03
2025-10-29
Company data provided by crunchbase