Senior Statistician

Senior Statistician – Penumbra, Inc.

Under general supervision of the Statistics Project Manager or higher, the Senior Statistician will perform methodology research and provide statistical expertise for the design, analysis, and reporting for assigned clinical studies. The Senior Statistician will conduct independent consultation across functional teams as needed. The incumbent may participate in planning meetings with strategic teams for purposes of identifying and communicating necessary statistical approaches to meet research and clinical trial objectives.

The Senior Statistician will liaise with medical writers and study investigators in preparing research manuscripts for publication.

• Develops statistical methods and relevant sections of major deliverables such as protocols, analysis plans, study reports and scientific publications.
• Responsible for sample size estimation and justification.
• Responsible for randomization specifications using standard methodology. Develops complex randomization specifications with supervision.
• Works with external vendors to effectively implement the randomization schedule.
• Supports submission activities and documents, provides input on responses to regulatory authorities and other device development activities, as required.
• Contributes to decision making on CRF data collection to ensure alignment with protocol objectives and statistical analyses defined in the protocol.
• Actively participates in meetings to identify data collection instruments and database design requirements.
• Authors statistical analysis plans, including interim analysis and stopping rules, ensuring statistical methods and corresponding details are consistent with the study design, and sufficiently detailed for programming implementation including development of table and listing shells. Coordinates statistical analysis plans written by contractor or junior statisticians.
• Explains statistical concepts to non-statisticians to enhance their understanding of the analysis approach. Clearly communicates fundamental statistical concepts to statisticians and other personnel.
• Summarizes and presents results (verbal and written) clearly, including creating reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
• Independently identifies issues arising in the design, conduct or analysis of clinical trials and proposes alternative analysis strategies or other recommendations to address these issues.
• Uses statistical and medical understanding to propose and perform additional analyses appropriately.
• Works collaboratively with multi-function teams to complete project deliverables per agreed timelines.
• Ensures accuracy and internal consistency of report or publication, including text, tables, listings, and figures. Performs statistical QC for protocol, analysis plan, study report, and other major deliverables, including abstracts, oral and poster presentations and publications.
• Collaborates in publication of scientific research results in assigned areas. Works with project team to develop strategy for data presentation.
• Identifies and recommends corrections of flaws in scientific logic and statistical interpretation.
• Ensures consistency in presentation, inference, and adherence to accepted report guidelines and publication practices.
• Provides critical review to enhance quality of data presentation and scientific/statistical arguments.
• Participates in departmental activities including recruiting, training, mentoring, and cross-functional collaborations, as needed.
• Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and by attending conferences and workshops, opportunity permitting.
• Presents own statistical research or review of the statistical literature at meetings and seminars.
• Demonstrates ability to act as a resource for other statisticians about a broad spectrum of analysis methods.
• Possesses broad programming abilities and shares them with others by consultation and example.
• Maintains programming skills even when delegating many programming tasks to others.
• Able to guide, negotiate, and coordinate all statistical project responsibilities independently.
• Collaborates with project team members, including the project lead, investigators, statistical colleagues in manner that consistently demonstrates a high level of expertise, experience, and professionalism.
• Adheres to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understands relevant security, privacy and compliance principles and adheres to the regulations, standards, and procedures that are applicable to the Company.
• Ensures other members of the department follow the QMS, regulations, standards, and procedures.
• Performs other work-related duties as assigned.