Principal Biostatistician
Company: CSL Behring
Location: King of Prussia
Posted on: January 12, 2026
|
|
|
Job Description:
Job Description 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 Biostatistician? The job is in our
King of Prussia, PA, Waltham MA and Maidenhead UK office. This is a
hybrid position and is onsite three days a week. You will report to
the Director of Biostats. You will lead components of statistical
contribution to a clinical development program. The Principal
Biostatistician implements the statistical strategies for the
clinical trials and regulatory submissions within the program, and
is accountable for the statistical deliverables Main
Responsibilities: Input to statistical strategy and ensure
appropriate statistical methodologies applied to study design and
data analysis for clinical trials and regulatory submissions. Lead
components and fully support Biostatistics conduct in study design,
protocol development, data collection, data analysis, reporting,
and submission preparation. Author the initial statistical analysis
plan for clinical trials and regulatory submissions. Be accountable
for timely completion and quality of the statistical analysis plan.
Support Biostatistics interactions with regulatory authorities (eg
FDA, EMA, PMDA) Be responsible for interpreting analysis results
and ensuring reporting accuracy. Manage outsourcing operations or
work with internal statistical programmers within the responsible
projects. Ensure timeliness and quality of deliverables by CRO/FSP.
Conduct reviews of deliverables to ensure quality. Be accountable
for the TFL/CDISC package for study report and regulatory
submission. Provide statistical thought partnership for innovative
study design and clinical development plans, including Go-No Go
criteria and probability of technical success calculations
Qualifications and Experience Requirements: PhD or MS in
Biostatistics, Statistics 7 years or relevant work experience
Experience with CROs (either managing a CRO, or having worked in a
CRO) Experience providing statistical leadership at a study level
Demonstrated statistical contribution in facilitating and
optimizing clinical development LI-HYBRID Our Benefits CSL
employees that work at least 30 hours per week are eligible for
benefits effective day 1. We are committed to the wellbeing of our
employees and their loved ones. CSL offers resources and benefits,
from health care to financial protection, so you can focus on doing
work that matters. Our benefits are designed to support the needs
of our employees at every stage of their life. Whether you are
considering starting a family, need help paying for emergency back
up care or summer camp, looking for mental health resources,
planning for your financial future, or supporting your favorite
charity with a matching contribution, CSL has many benefits to help
achieve your goals. Please take the time to review our benefits
site to see what’s available to you as a CSL employee. About CSL
Behring CSL Behring is a global biotherapeutics leader driven by
our promise to save lives. Focused on serving patients’ needs by
using the latest technologies, we discover, develop and deliver
innovative therapies for people living with conditions in the
immunology, hematology, cardiovascular and metabolic, respiratory,
and transplant therapeutic areas. We use three strategic scientific
platforms of plasma fractionation, recombinant protein technology,
and cell and gene therapy to support continued innovation and
continually refine ways in which products can address unmet medical
needs and help patients lead full lives. CSL Behring operates one
of the world’s largest plasma collection networks, CSL Plasma. Our
parent company, CSL, headquartered in Melbourne, Australia, employs
32,000 people, and delivers its lifesaving therapies to people in
more than 100 countries. We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and
who we are. It fuels our innovation day in and day out. By
celebrating our differences and creating a culture of curiosity and
empathy, we are able to better understand and connect with our
patients and donors, foster strong relationships with our
stakeholders, and sustain a diverse workforce that will move our
company and industry into the future. Learn more Inclusion and
Belonging | CSL. Do work that matters at CSL Behring!
Keywords: CSL Behring, Philadelphia , Principal Biostatistician, Science, Research & Development , King of Prussia, Pennsylvania