Biostatistician I

Overview

• Contribute to clinical trial design and analysis using advanced statistical methodologies.
• Collaborate with multidisciplinary teams to ensure high-quality deliverables and adherence to timelines.
• Apply regulatory guidelines and industry standards to statistical projects.
• Develop and maintain knowledge of current statistical methods and applications.
• Manage CROs effectively to ensure project success within budget constraints.
• Participate in validation and quality control processes for study endpoint analysis.
• Provide statistical expertise and recommendations for clinical trial phases I-III.
• Contribute to the creation of interim and final reports, publications, and submission deliverables.

Key Responsibilities & Duties

• Develop clinical protocols, statistical analysis plans, and CRF templates.
• Perform statistical analyses and interpret study results collaboratively with clinical teams.
• Manage CROs to ensure deliverables meet quality standards and timelines.
• Validate and perform quality control on key study endpoint analyses.
• Ensure compliance with regulatory guidelines and industry standards.
• Contribute to SDTM/ADaM specification development and review.
• Represent biostatistics in multidisciplinary meetings and collaborations.
• Provide guidance and mentorship to team members and subordinates.

Job Requirements

• Doctorate degree (PhD) in a relevant discipline.
• Minimum of 1 year of experience; 6 years preferred.
• Proficiency in SAS programming and statistical applications.
• Experience in oncology and clinical trial phases I-III preferred.
• Capability to manage CROs and ensure quality deliverables.
• Knowledge of regulatory guidelines and industry standards.
• Strong analytical and business communication skills.
• Ability to work on complex issues requiring evaluation of intangibles.