We are seeking an experienced and proactive Principal

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 standardsRequired 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