Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.
As a Biostatistician you are 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 Triangle Biostatistics’ and/or sponsor Standard Operating Procedures (SOPs) or study specific guidelines.
Position Responsibilities/Accountabilities:
- Work with project team personnel (from Sponsor company, external vendors, and within Triangle Biostatistics) 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 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.
Position Qualification 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 1-2 years of relevant work experience. Previous experience in a pharmaceutical research or CRO setting required/preferred.
Required Skills:
- Knowledge of clinical trial study design.
- Able to work independently on multiple, concurrent projects.
- Can attend 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 frequently for meetings or training activities may be required.
