We are seeking an experienced and proactive
Senior Biostatistician
to join our FSP team, supporting a global pharmaceutical client. This is a
permanent, home-based
position offering the opportunity to work on
late-phase global oncology trials, with a focus on
hematology
and
regulatory submissions .
Key Responsibilities
Serve as the
lead statistician
on global
late-phase registration trials, particularly in oncology (hematology preferred). Independently contribute to
study design ,
statistical analysis plans (SAPs), and
regulatory submission strategies. Participate in
study team meetings, providing statistical guidance and collaborating with cross-functional teams. Address
health authority questions
and support responses with appropriate statistical analyses and documentation. Perform
hands-on statistical programming
to derive outputs and summary statistics using
ADaM
and
SDTM
datasets. Ensure timely and accurate delivery of statistical deliverables in compliance with regulatory standards Required Qualifications Advanced degree (Master's or PhD) in
Biostatistics ,
Statistics, or a related field. 5+ years
of experience in clinical trials, with a strong focus on
oncology
(hematology and late-phase preferred). Proven experience working on
registrational studies
and
regulatory submissions. Strong knowledge of
CDISC standards, particularly
ADaM
and
SDTM. Proficiency in
SAS
programming and ability to perform hands-on statistical analyses. Excellent communication skills and ability to work independently in a global, cross-functional environment. Preferred Experience Prior involvement in
FDA/EMA submissions. Experience addressing
regulatory agency queries. Familiarity with
real-world evidence
and
observational studies
is a plus. Why Join Us? Work on
high-impact global studies
with a focus on improving cancer treatment outcomes. Be part of a
collaborative and innovative
team environment. Enjoy the
flexibility of remote work
with a permanent contract. Gain exposure to
regulatory strategy
and
cutting-edge oncology research. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com #J-18808-Ljbffr