Catalyst Clinical Research is a niche provider of clinical research services through two established solutions- Catalyst Flex and Catalyst Oncology. Here at Catalyst Clinical Research we provide support and services exclusively to biotech companies because we know and understand the biotech environment. Our 15 years of experience allow us to quickly grasp the evolving needs of our clients so we can deliver the solutions essential to meet the evolving needs and unexpected changes inherent in oncology development. When protocols amend or emerging data suggest a breakthrough straight from Phase I to registration, we are ready.

Position Summary: As a Biostatistician II you will be a key member of the Clinical Development Operations, Biostatistics Team. You will plan, analyze, and summarize the results of individual clinical studies or groups of studies (integrated summaries) and coordinate the development and review of regulatory submissions (e.g., NDAs). Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Catalyst Clinical Research Biostatistics’ and/or sponsor Standard Operating Procedures (SOPs) or study specific guidelines.  

Position Accountabilities/Responsibilities:

• Work with project team personnel (from Sponsor company, external vendors, and within the Catalyst Clinical Research Biostatistics team) from Biostatistics, Programming, Clinical Research, Data Management, and other departments as needed to meet project deliverables and timelines for statistical data analysis and reporting. 
• Provide sample size calculations and reviews protocols for completeness. 
• Provide randomization schemes and appropriate documentation per SOPs. 
• Monitor project budgets as it relates to the scope of work and support project forecasting efforts. Serve as project manager when a clinical development PM does not exist, in management of timelines.
• Contribute to departmental initiatives. 
• Serve as subject matter expert for the Biostatistics and Programming teams as needed. 
• Provide statistical advice/recommendations regarding clinical study design/study endpoints, sample size requirements, statistical methodology for the study protocol and clinical study report, and document (e.g., protocol, clinical study report, common technical documents) review/approval. 
• Author statistical analysis plans and study specifications. 
• Serve as the primary statistical contact for the study/project team.  
• Use knowledge of regulatory agency (e.g., FDA) requirements and guidance documents to provide statistical advice with respect to creating a clinical development program. 
• Use knowledge of literature to provide data analysis and presentation methods to support publications/presentations

Supervisory Requirements/Responsibilities: N/A

Position Qualifications and Requirements:

Education:

Master’s degree, equivalent, or higher in Biostatistics or a related field. (A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience.) 

Experience:

A minimum of 2 years of relevant work experience. Previous experience in a pharmaceutical research or CRO setting required/preferred.

Required Certifications: N/A

Required Skills:

• Knowledge of clinical trial study design.  
• Able to work independently on multiple, concurrent projects.  
• Leads study team meetings as needed. 
• 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, flexibility, and a willingness to work within constantly changing priorities. 
• Proven ability to handle multiple projects and meet deadlines. 
• Strong interpersonal skills. 
• 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 may be required. 

Working Conditions: ​​Sedentary work that primarily involves sitting/standing​.

Catalyst Clinical Research, LLC is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.