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Penumbra, Inc. · 1 day ago

Senior Statistician

United States

Full-time

Remote

Mid, Senior Level

$127K/yr - $207K/yr

6+ years exp

Penumbra is a global healthcare company focused on innovative therapies, and they are seeking a Senior Statistician to provide statistical expertise for clinical studies. This role involves methodology research, statistical consultation, and collaboration with multi-functional teams to ensure the integrity and quality of statistical analysis and reporting.

Medical Device

H1B Sponsor Likely

Responsibilities

Develops statistical methods and other 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

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

Qualification

Statistical analysisClinical trial designFDA regulatory knowledgeBiostatisticsProgramming skillsInterpersonal skillsOrganizational skillsCommunication skills

Required

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

Competent in study design, descriptive and inferential statistics, clinical trial applications and computer programming

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

Preferred

Understanding of FDA regulatory requirements and ICH/GCP preferred

Benefits

Medical

Dental

Vision

Life

AD&D

Short and long-term disability insurance

401(k) with employer match

An employee stock purchase plan

Paid parental leave

Eleven paid company holidays per year

A minimum of fifteen days of accrued vacation per year, which increases with tenure

Paid sick time in compliance with applicable law(s)

Company

Penumbra, Inc.

Glassdoor3.3

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.

Founded in 2004

Alameda, CA, US

1001-5000 employees

http://www.penumbrainc.com

H1B Sponsorship

Penumbra, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (36)

2024 (42)

2023 (46)

2022 (43)

2021 (36)

2020 (26)