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The Opportunity
Description
We're looking for a Biostatistician Manager , working in Pharmaceuticals and Medical Products industry in 155 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, United States .

• Participate in study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc.
• Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others.
• Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT).
• Generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
• Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables.

Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20 years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success

• MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry
• Strong SAS programming skills
• Oncology experience is required
• Ability to effectively work on multiple projects
• Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality
• Applies good judgment and leads problem solving within the team
• Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus

What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?