Senior Biostatistician

Catalyst Clinical Research - Raleigh, NC

Full-time - Senior

Raleigh, NC

Administrative and Support Services

About the position

As a Senior Biostatistician at Catalyst Clinical Research, you will play a crucial role in the Oncology Operations, Biostatistics Team. This position involves serving as the primary statistical representative for complex studies and managing broad-based projects such as NDA submissions. You will develop and review statistical analysis plans, assist in creating analysis datasets, and provide oversight to junior biostatistics staff.

Responsibilities

• Lead low to high complexity studies in various phases of development.
• Provide senior oversight on low or moderate complexity studies.
• Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs.
• Collaborate with internal and external project team personnel to meet project deliverables and timelines.
• Interact with project team and line manager to identify project priorities and communicate activities and timelines.
• Serve as primary statistical representative for biometrics standalone projects or complex studies.
• Represent department and company in multi-disciplinary settings, including project team meetings and client presentations.
• Provide statistical advice regarding clinical study design, sample size requirements, and statistical methodology.
• Develop and review statistical analysis plans based on study specific documents.
• Assist in developing and maintaining ADaM specifications for analysis datasets, tables, listings, and figures.
• Ensure quality and integrity of data analysis and reporting by programming checks using SAS.
• Monitor project budgets and support project forecasting efforts.

Requirements

• Master's degree or higher in biostatistics or a related field.
• Minimum of 5+ years of relevant work experience.
• Previous experience in pharmaceutical research or CRO setting required.
• Prior experience in multiple therapeutic areas, with experience in Oncology preferred.
• Knowledge of clinical trial study design and multiple therapeutic areas.
• Ability to work independently on multiple, concurrent projects.
• Capable of conducting exploratory statistical analyses using statistical software packages.
• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility and flexibility in adapting to changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Good judgement with the ability to make timely and sound decisions.
• Ability to travel for meetings or training activities.
• Ability to program simple checks for ADaM or TLF review using SAS and/or R.
• Excellent presentation skills.