Senior Biostatistician

Theradex Oncology; Princeton (NJ); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision plans

401(k) matching

Tuition reimbursement

Generous vacation/sick leave

Flexible work schedules

Job summary

Theradex Oncology is seeking a senior biostatistician to lead statistical deliverables across oncology trials. You will write and review SAPs, assist in protocol design, and generate SAS analyses while ensuring quality and regulatory compliance.

The role requires a Master’s in Biostatistics and 5+ years in clinical biostatistics within a CRO/pharma setting, with oncology trial experience preferred. Strong communication and project management skills are essential.

Qualifications

• Master’s degree in Biostatistics or equivalent is required.
• 5+ years of experience in clinical biostatistics is required.
• CRO/pharmaceutical environment experience preferred.
• Oncology trials experience preferred.

Responsibilities

• Ensure high-quality statistical deliverables.
• Write/review SAPs (Statistical Analysis Plans).
• Design protocol studies and determine sample sizes.
• Write TLF (Tables, Listings, Figures) plans.
• Review CRFs and randomization/blinding plans.
• Develop/validate SAS code for analyses.
• Maintain study documentation and CSR reviews.
• Stay current with statistical literature and methods.

Skills

Statistical design

Drug development

Communication

Project management

Risk assessment

Time management

SOP knowledge

FDA/ICH guidelines

Education

Master’s degree in Biostatistics or equivalent

Tools

MS Office

Outlook

Job description

Who We Are

Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. 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

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.

Your primary responsibilities will include the following:

• Ensures successful completion of high-quality statistical deliverables


• Writes and/or reviews statistical sections of protocols


• Assists in protocol study design (determines sample sizes for all phases of trials)


• Writes Statistical Analysis Plans (SAPs)


• Writes Tables, Listings and Figures Plans (TLF Plans)


• Reviews and/or designs Case Report Forms (CRFs)


• Reviews and/or writes randomization and blinding plans


• Reviews and/or writes charters for Data Monitoring Committees (DMCs)


• Provides SAS code for statistical models


• Validates/performs SAS programming for key data analyses


• Performs quality control on derived variables being analyzed


• Interprets results from analysis


• Maintains documentation


• Reviews Clinical Study Reports (CSR)


• Keeps abreast of statistical literature/design

What You Need

Level of Education

• Master’s degree in Biostatistics or equivalent, required

Prior Experience

• 5+ years of experience in clinical biostatistics, required


• Prior experience in a CRO/pharmaceutical environment, required


• Oncology clinical trials preferred


• Experience with phase I trials preferred

Skills and Competencies

• Expertise in statistical concepts and design


• Understands the investigational drug development process


• Demonstrates ability to build and maintain effective relationships with others


• Strong communication, organizational and decision-making skills


• High level of agility and diplomacy


• Must be able to anticipate challenges and project risks and proactively implement solutions


• Strong time management and effective planning skills


• Knowledge of Standard Operating Procedures


• Working knowledge of FDA and ICH guidelines


• Working knowledge of MS Office and Outlook

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 and 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.