Position Summary:

The Sr. Biostatistician will play a crucial role in the design, analysis, and interpretation of clinical trials and observational studies. This position requires strong statistical expertise, leadership capabilities, and the ability to collaborate effectively with cross-functional teams. The Biostatistician will focus on statistical aspects of study design, protocol review, and preparation of statistical sections; preparation of the statistical analysis plan; oversight of tables/listings/figures development; interpretation of results to internal clinical and management personnel; and support of the preparation of publications and submissions of regulatory deliverables. In providing clinical trial support, this person will participate in management of external resources to ensure quality, timely, and cost-effective statistical deliverables.

This role is a US remote-based position.  

Responsibilities:

• Acts as main statistical contact for the assigned studies and projects
• Understand the disease area and disease guidelines, and evaluating the data from the competitive landscaping
• Provide statistical input into the preparation of regulatory submissions (e.g., INDs, NDAs, BLAs), ensuring adherence to regulatory guidelines
• Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR)
• Execute statistical activities for medium to high complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, data surveillance review, statistical analysis accuracy validation, results interpretation and CSR input and review
• Provides guidance to study team on all aspects of statistical activities
• Collaborate with cross-functional teams including clinical operations, data management, medical writing, HEOR,  and regulatory affairs to ensure study objectives are met
• Manage CRO/vendor oversight to include:
  • Review budgets and proposals
  • Set expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies
  • Ensures deliverables are accurate and delivered according to the timelines
• Maintain knowledge of current industry practices and regulatory requirements related to biostatistics
• High attention to detail and proficiency in producing organized reports

Education/Experience/ Skills: 

• Ph. D in statistics with biostatistics training or equivalent field. 
• Minimum of 5 years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry.
• Strong knowledge of evolving statistical methodologies with knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation
• Solid understanding of current drug development trends and regulatory environments
• Proficiency in statistical software packages
• High attention to details and proficiency in producing organized reports
• Excellent communication skills with the ability to explain complex statistical concepts to non-statistical colleagues

EEO Statement
Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.  

Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.