This position is 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.
Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.
Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
Provides independent review of project work produced by other biostatisticians in the department.
Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
Collaborates with sponsor, if required.
May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
Creates or reviews programming specifications for analysis 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.
Implements company objectives, and creates alternative solutions to address business and operational challenges.
As biostatistics representative on project teams, interfaces with other departmental project team representatives
Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.
May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to 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 ensures the study timelines for project deliverables are met.
Identifies out of scope tasks and escalates to management.
Provides statistical programming support as needed.
May participate in Data Safety Monitoring Board (DSMB) and / or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician.
May serve as a voting statistician on DSMBs and / or DMCs.
Provides input and reviews, and subsequently 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.
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
Performs other work-related duties as assigned.
Minimal travel may be required.
Graduate degree in biostatistics or related discipline.
Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.
Proficiency in programming.
Ability to apply extensive 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.
Experience with regulatory submissions preferred.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.