Senior Biostatistician

Theradex Oncology; United States; On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical, dental and vision

Life insurance

Disability insurance

401(k) matching

Tuition reimbursement

Vacation and sick leave

Flexible work schedules

Employee discounts

Job summary

Theradex Oncology is seeking a Senior Biostatistician to lead the statistical strategy for cutting-edge cancer trials. Join one of the largest teams dedicated to developing cancer therapies and support sponsors in bringing novel therapies to patients.

You will design, analyze, and report on trials in a CRO environment, contributing to high-quality regulatory deliverables and rigorous documentation.

Qualifications

• Master’s degree in Biostatistics or equivalent.
• 5+ years of experience in clinical biostatistics.
• Experience in a CRO/pharmaceutical environment.

Responsibilities

• Protocol design & trial planning: write/review statistical sections, randomization plans, DMC charters.
• Statistical programming & analysis: write SAPs and TLF plans; provide SAS code for models; validate analyses.

Skills

Biostatistics

Clinical trials

Statistical methods

Cross-functional collaboration

Education

Master's degree in Biostatistics

Tools

SAS

MS Office

Job description

Theradex Oncology is a full-service CRO specializing in oncology for over 40 years. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

What You'll Do

Are you ready to lead the statistical strategy for cutting-edge cancer trials? We are hiring a Senior Biostatistician.

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

Responsibilities:

Protocol Design & Trial Planning

• Write and/or review statistical sections of protocols.
• Review and/or write randomization, blinding plans, and Data Monitoring Committee (DMC) charters.
• Keep abreast of relevant statistical literature and study designs.

Statistical Programming & Analysis

• Write Statistical Analysis Plans (SAPs) and Tables, Listings, and Figures (TLF) Plans.
• Provide SAS code for statistical models and validate/perform SAS programming for key data analyses.
• Perform quality control on derived variables being analyzed.
• Interpret analysis results accurately.

Reporting & Documentation

• Ensure successful completion of high-quality, regulatory-compliant statistical deliverables.
• Maintain rigorous study documentation.

What You Need

Required:

• Master’s degree in Biostatistics or equivalent
• 5+ years of experience in clinical biostatistics
• Prior experience in a CRO/pharmaceutical environment

Preferred:

• Oncology clinical trials
• Experience with phase I trials
• Statistical Design: Expertise in statistical concepts, clinical study design, and data analysis.
• Compliance & Standards: Adherence to SOPs, FDA regulations, and ICH guidelines.
• Strategic Planning: Risk assessment, proactive project risk mitigation, and issue resolution.
• Time Management: Effective planning, prioritization, and execution of trial deliverables.
• Cross-Functional Collaboration: Relationship-building across teams and departments.
• Strategic Communications: Agile, diplomatic, and clear communication in fast-paced environments.
• Software Proficiency: MS Office, MS Outlook, and data/documentation management.

What We Offer

At Theradex we offer a supportive culture that puts people first.

Our employees are eligible to participate in our comprehensive benefits package which includes:

• medical, dental and vision coverage
• life insurance
• disability insurance (STD/LTD)
• company matched 401(k)
• very competitive tuition reimbursement
• generous vacation/sick plans
• flexible work schedules
• employee discounts
• other company provided benefits

The annual base salary for this position ranges from $130,000-$160,000. The actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role.

This position is not eligible for relocation or company provided sponsorship.

Theradex is an Equal Opportunity Employer.