Duty assignments

• Helps prepare statistical analysis plans (SAPs), including mock-ups for tables, listings, and figures. As needed, collaborate with senior biostatistics staff and sponsor.
  Lead Biostatistician responsible for statistical components of protocol, randomization schedule, and clinical study report.
• As a biostatistician, assist senior staff with statistical duties (e.g., randomization, sample size estimation).
• Creates or reviews analytical dataset, table, listing, and figure programming requirements.
• Examines case report forms (CRFs), database design, and other study documents to ensure protocol criteria are followed and all data is recorded to enable a high-quality database and planned analysis.
• Participates in project verification and quality control, ensuring output meets expectations and is compatible with SAP analysis and specifications.
• Manages scheduling and time limitations across various projects, sets targets based on Lead Biostatistician and management priorities, adjusts to timetable or priority changes by restructuring daily workload, and proactively discusses challenges reaching timeframes.
• Monitors study progress against milestones and ensures project deadlines are reached. Identifies and escalates out-of-scope tasks.
• Assists with statistical programming.
• Prepares for meetings, offers suggestions, and respects others’ viewpoints.
• Follows SOPs, WIs, and regs (e.g. ICH).
• Keeps project documentation, verification/quality control records, and programs organized, complete, and up-to-date to ensure inspection preparedness.
• Shows desire to collaborate with others and helps with corporate ideas and efforts.
• Attending bid defense meetings may promote business development.
• Assigned work-related duties.

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Possible travel requirements may be minimal.

Qualifications

• What we want to find
• Biostatistics or a related field at the graduate level.
• Moderate experience with clinical trials or a combination of education and experience that is about the same.
• Experience with programming, preferably in a clinical trials setting.
• Ability to use knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques used in clinical research and to effectively communicate statistical concepts.
• Excellent communication skills both in writing and in person.
• English reading, writing, speaking, and understanding.