Senior Biostatistics Director - Oncology Trials (Remote)

BeiGene, Ltd.; United States; Remote; USD 163,000 - 213,000; Full time

Benefits offered by this job

Medical insurance

Dental Insurance

Vision Insurance

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness programs

Job summary

BeOne Medicines Ltd. is seeking an Associate Director of Biostatistics to lead statistical strategy for hematology studies. You will review data, develop SAPs for CSR submissions, and coordinate statistics activities across cross-functional teams, including Clinical, Regulatory, and Data Management.

The role requires a PhD in Statistics or related field with 5+ years in clinical drug development, or a Masters with 8+ years. Strong SAS/R programming and regulatory knowledge are essential.

Qualifications

• PhD in Statistics or related field with 5+ years of experience, or a Master’s degree with 8+ years in clinical drug development.
• Experience with clinical trials and knowledge of regulatory guidance.
• Oncology experience is preferred but not required.
• Demonstrated written and oral communication skills; ability to work in a team and independently.

Responsibilities

• Develops or assists development of study protocols and SAPs and determines appropriate statistical methodology.
• Participates in database design meetings to ensure data quality and analysis readiness.
• Collaborates with statistical programming to ensure programs meet analysis requirements and regulatory guidance.
• Analyzes data and interprets results from clinical trials to meet study objectives.
• Prepares reports to communicate results to the project team and stakeholders.
• Interacts with monitors/regulators to respond to study design and analysis queries.
• Engages in research for innovative statistical methods in clinical trial development.

Job description

BeOne Medicines Ltd. is seeking an Associate Director of Biostatistics to lead statistical strategy for hematology studies. You will review data, develop SAPs for CSR submissions, and coordinate statistics activities across cross-functional teams, including Clinical, Regulatory, and Data Management.

The role requires a PhD in Statistics or related field with 5+ years in clinical drug development, or a Masters with 8+ years. Strong SAS/R programming and regulatory knowledge are essential.