Senior Biostatistician

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BiostatisticianLaboratory & Life Sciences

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Quick Summary

Overview

Who We Are Celebrating 40+ years! Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs.

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BiostatisticianLaboratory & Life Sciences

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.

Responsibilities

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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

Requirements

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Master’s degree in Biostatistics or equivalent, required

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

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

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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.