Job responsibilities

• Prepares or assists in preparing statistical analysis plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with other senior biostatistics personnel as needed and with sponsor, if required.    
• May act as Lead Biostatistician, and be responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• As a supporting Biostatistician, provide assistance to senior staff members in the performance of statistical responsibilities (e.g., randomization, sample size estimation).Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Manages scheduling and time constraints across multiple projects, set goals based on priorities from Lead Biostatistician and management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to the Lead Biostatistician or Biostatistics management any difficulties with meeting these timelines.  
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.
• Provides statistical programming support as needed.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• May support business development activities by attending sponsor bid defense meetings.
• Performs other work-related duties as assigned.  
• Minimal travel may be required.

Qualifications

What we’re looking for

• Previous lead experience within Late Phase Clinical Trials is required.
• Graduate degree in biostatistics or related discipline.
• Moderate experience in clinical trials or an equivalent combination of education and experience.
• Programming experience, preferably in a clinical trials environment.
• Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.