Senior Biostatistician (Clinical Trial Experience Required)

📋 Description

• Serve as the lead Biostatistician for assigned clinical studies and act as the primary statistical
• Manage statistical activities against project timelines, proactively communicating schedule
• Review case report forms, completion instructions, database designs, and data-edit requirements to
• Develop or review Interim Analysis Plans, SAPs, statistical methods, and analysis specifications in
• Develop or review CDISC-compliant SDTM and ADaM dataset specifications, mock tables, listings
• Independently perform statistical analyses by programming derived datasets and TLFs, while

🎯 Requirements

• Master’s degree in Biostatistics, Statistics, or a closely related quantitative discipline.
• At least 4 years of relevant biostatistics experience within a pharmaceutical, CRO, clinical
• Demonstrated clinical trial experience with the ability to independently lead or oversee
• Hands-on experience with CDISC standards, including SDTM and ADaM dataset mapping and related
• Experience developing or reviewing Statistical Analysis Plans, Interim Analysis Plans, TLF
• Strong knowledge of clinical study design, endpoint development, power analysis, sample size

🎁 Benefits

• Fully remote work arrangement within the United States.
• Full-time position with opportunities to contribute to impactful clinical research programs.
• Structured mentoring and leadership development programs to support career progression.
• Ongoing professional education, training, and tuition reimbursement opportunities.
• Comprehensive health and wellness benefits.
• Generous vacation and paid time-off programs.