The company I am recruiting for is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. They serve some of the most well-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Quality is their backbone, customer-focus is their tradition, flexibility is their strength.

To drive continued success in this exciting clinical research field, this CRO is seeking a committed, skilled, and customer-focused individual to join their award winning team as Associate Director, Biostatistics (Statistical Operations).

QUALIFICATIONS

• PhD in Statistical Sciences with 10+ years of experience or Masters in Statistical Sciences with 13+ years of experience
• U.S. School Masters Degree or PhD Required
• Must have 10+ years of experience working as a Statistician at a CRO or Pharma

RESPONSIBILITIES

• Clinical Trial Management: Collaborate with senior directors to oversee clinical trial programs/projects for multiple clients. Provide technical and operational leadership to project teams.
• Mentoring and Development: Coach, mentor, and advise subordinate Biostatisticians and Statistical Programmers. Contribute to performance evaluations and developmental plans.
• Statistical Leadership: Lead statistical and programming teams, ensuring quality deliverables. Interact with clients and internal project leaders to plan and implement statistical project plans.
• Methodological Expertise: Ensure robust statistical methodologies in study design, sample size estimation, data handling, modeling, and reporting.
• Protocol Input: Provide statistical input during protocol design and participate in writing trial protocols and research proposals.
• Strategic Contribution: Work as a principal-level Biostatistician, contributing strategically to drug development and commercialization across study and therapeutic areas.
• Data Management Review: Review clinical data management deliverables, including eCRFs, data validation specifications, and data review tables.
• Regulatory Compliance: Ensure all statistical and programming activities at study and drug program levels adhere to relevant regulatory requirements and standards.
• Agency Interaction: Interact with regulatory agencies and support sponsors during new drug applications. Serve as a statistical liaison, ensuring compliance with documentation and CDISC requirements.
• Resource Management: Manage statistical and programming resources, analyze capacity, benchmark performance, and contribute to governing document maintenance.
• Organizational Development: Participate in interviewing and evaluating professional applicants to foster organizational growth.
• Business Development: Assist in estimating costs for statistical and programming services and contribute to business development activities.

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