General Summary
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.
Specific Duties and Responsibilities
•Develops statistical methods and other relevant sections of major deliverables such as protocols, analysis plans, study reports and scientific publications. Prepare key sections of clinical study reports and various regulatory documents.*
•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.
•Support submission activities and documents, provide input on responses to regulatory authorities and other device development activities, as required.
•Contribute 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.
•Author 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. Coordinate statistical analysis plans written by contractor or junior statisticians.*
•Explain statistical concepts to non-statisticians to enhance their understanding of the analysis approach. Clearly communicate 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.
•Identify and recommend 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.
•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
•Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
•Ensure other members of the department follow the QMS, regulations, standards, and procedures.*
•Perform other work-related duties as assigned.
*Indicates an essential function of the role
Position Qualifications
Minimum education and experience:
•Master’s degree in Statistics, Biostatistics, Math or other scientific discipline with 6+ (six) years of experience or Bachelor’s degree with 8+ years of experience in Clinical trial analysis in a medical device or pharmaceutical environment, or an equivalent combination of education and experience.
Additional qualifications:
•Competent in study design, descriptive and inferential statistics, clinical trial applications and computer programming.
•Understanding of FDA regulatory requirements and ICH/GCP preferred.
•High degree of accuracy, organizational skills and attention to detail are essential.
•Experience analyzing complex study objectives and developing appropriate analysis specifications and plans.
•Exercising judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
•Builds strong relationships with peers and cross functionally with partners outside of team Experience writing statistical analysis plan (SAP) from the clinical protocol and other study specific documents.
•Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
•Able to work under time pressure and handle multiple tasks simultaneously.
•Determines methods and procedures on new assignments and may coordinate activities of other personnel. Strong interpersonal, collaborative and communication skills are required.
Annual Base Salary Range: $127,000 - $207,000
This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
