Senior Biostatistician

Theradex Oncology Job OpportunityTheradex 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 DoAs 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 deliverablesWrites and/or reviews statistical sections of protocolsAssists 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 plansReviews and/or writes charters for Data Monitoring Committees (DMCs)Provides SAS code for statistical modelsValidates/performs SAS programming for key data analysesPerforms quality control on derived variables being analyzedInterprets results from analysisMaintains documentationReviews Clinical Study Reports (CSR)Keeps abreast of statistical literature/designWhat You NeedLevel of EducationMaster's degree in Biostatistics or equivalent, requiredPrior Experience5+ years of experience in clinical biostatistics, requiredPrior experience in a CRO/pharmaceutical environment, requiredOncology clinical trials preferredExperience with phase I trials preferredSkills and CompetenciesExpertise in statistical concepts and designUnderstands the investigational drug development processDemonstrates ability to build and maintain effective relationships with othersStrong communication, organizational and decision-making skillsHigh level of agility and diplomacyMust be able to anticipate challenges and project risks and proactively implement solutionsStrong time management and effective planning skillsKnowledge of Standard Operating ProceduresWorking knowledge of FDA and ICH guidelinesWorking knowledge of MS Office and OutlookWhat We OfferAt 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.