The company is looking for a Principal Biostatistician who will be responsible for leading projects across multiple studies or programs. A Principal Biostatistician acts as the primary contact with the sponsor for all biostatistics-related activities on assigned projects. Provides external statistical consultancy for sponsor companies, and serves as a departmental resource for complex statistical questions, study design considerations, and protocol development.
- Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
- Prepares Statistical Analysis Plans (SAPs), including the development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
- May be responsible for the statistical aspects of the protocol, generation of the randomization schedule, publications, and input to the clinical study report.
- Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure the timely completion of high-quality work. Provides an independent review of project work produced by other biostatisticians in the department.
- Creates or reviews programming specifications for analysis of datasets, tables, listings, and figures.
- Reviews SAS 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 the analysis described in SAP and specifications.
- Implements company objectives, and creates alternative solutions to address business and operational challenges.
- Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for the opinions of others.
- Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to the timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
- Monitors progress on study activities against agreed-upon milestones and ensure the study timelines for project deliverables are met. Identifies out-of-scope tasks and escalates to management.
- Provides statistical programming support as needed.
- Master's Degree in Statistics or related discipline.
- Min 5 years of relevant experience as Statistician in a clinical trials environment working on Late phase studies and preferably 1 year as study lead.
- Good proficiency in programming.
- Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
- Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
Immediate joiner or a maximum of 30 days
- Life Sciences
- Job Level
- Senior Management
- 8 - 12 (in years)
- Reporting To
- Company Name
- Company Size