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 .

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.

• 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