Biostatistician (Evergreen)

Terumo Neuro; United States; Hybrid; USD 123,000 - 164,000; Full time

Benefits offered by this job

PTO 15 days

Tuition reimbursement

Hybrid/Remote options

DEI focus

Job summary

Terumo Neuro is seeking a Biostatistician to lead the application of statistical methods across clinical trials and post-market analyses. You will design studies, develop SAPs, and guide cross-functional teams to ensure robust analyses.

You will generate SAS outputs for submissions, contribute to protocol development, and stay current with FDA guidance and data standards while supporting regulatory and medical affairs. Travel up to 10% may be required.

Qualifications

• PhD in biostatistics or statistics.
• At least five years of statistical methods experience in pharma/biotech.
• At least one year of lead or management experience.
• Excellent written and verbal communication skills.
• Proficient with Microsoft Office suite.

Responsibilities

• Lead statistical design and analysis for clinical trials and post-market data.
• Develop SAPs for all study phases and ensure alignment with protocols.
• Produce SAS tables, figures, and reports for submissions and publications.
• Provide statistical consultation to cross-functional clinical and regulatory teams.
• Create SOPs for analysis of clinical study data and QA of statistical outputs.
• Support Regulatory Affairs, QA, and Medical Affairs with data reviews.
• Stay current with regulatory guidance (FDA/ICH) and data standards.
• Travel up to 10% domestically/internationally.

Skills

Leadership/management

Communication

Project management

Statistical knowledge

Education

Ph.D. in biostatistics or statistics

Tools

SAS

Oracle Clinical

UNIX

S-plus/R

Microsoft Office

Job description

Working for a company voted Great Places to Work - 2022, the Biostatistician leads and drive the application of statistical and research methodological principles for the design, execution, and analysis of clinical trials as well as post-market data analysis projects.

What You'll Be Doing

Ensure all the data analysis activities are conducted in accordance with regulatory and company standards. Job duties:

• Oversee the development and execution of various clinical and technical training programs.
• Provide technical/statistical leadership and strategic input to clinical projects in collaboration of cross-functional teams
• Contribute to the development and documentation of clinical study protocols and Case Report Forms (CRFs) and have the primary responsibility for developing the statistical section of the review and assessment of protocol deviations to the extent that they affect statistical analyses
• Develop the statistical analysis plan for all phases of clinical studies to ensure consistency with the protocol and adequacy to meet objectives defined in protocol under limited supervision
• Generate statistical summary tables, graphs, and reports using SAS for regulatory submissions, conference presentations, and/or marketing publications
• Provide consultation to clinical and regulatory project teams on any statistical issues related to trial conduct
• Support Medical Affairs with literature reviews and related activities
• Contribute to peer-reviewed articles independently, in coordination with the lead author/physician
• Complete meta-analyses of published clinical data to support medical affairs, regulatory and marketing objectives
• Institute and perform complex statistical techniques to review and analyze clinical data; provide defense for and justification of statistical hypothesis, objectives, and designs
• Lead and drive the development of data quality standards; develop programs that satisfy the standards where needed; and provide quality control for statistical programs and methodology
• Responsible for the development and review of standard operating procedures for the analysis of clinical study data
• Provide statistical support to Regulatory Affairs, Quality Assurance, product development, Scientific and Medical Affairs and other areas of the company as directed. May assist in preparing materials for presentation at professional meetings
• Stay current with statistical methodology in clinical trial design and analysis
• Domestic/international travel required, up to 10%

The Skills/Experience Needed for the Role

• Ph.D. in biostatistics or statistics
• A minimum of five (5) years of statistical methods experience within the pharmaceutical, medical device, or biotechnology industry
• A minimum of one (1) year of lead, supervisory or management responsibility
• Excellent written and verbal communication skills
• Proficient with Microsoft Access, Excel, Word, PowerPoint, SharePoint, Visio, and Project

How to Stand out from the Crowd

• Proficient in SAS. Familiarity with other statistical packages for handling smaller datasets and power analyses
• In-depth understanding of descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests
• Experience with Bayesian statistics, adaptive design, and other innovative statistical methodologies. Knowledge of industry standards and best practices in data management and applicable country regulations (US FDA, ISO, ICH, CDISC)
• Knowledge of US law, regulations, and FDA guidance covering good clinical practice (GCP)
• Knowledge of meta-analyses and simulation techniques
• Experience with Data Management Systems such as Oracle Clinical
• Knowledge of Bayesian statistics
• Experience with the UNIX operating as well as with other statistical software including S-plus/R
• Ability to handle multiple projects, attention to detail, and demonstrated problem solving and judgment skills

Salary Range

$123,318-$164,424 (Compensation could be higher or lower based on education, experience, location and skill sets)

• 15 Days of PTO, 12-13 Paid Holidays, and offices closed last week of December (paid).
• Tuition Reimbursement up to $10,000/Year
• On-Site/Hybrid/Remote Work Schedules
• Focus on Diversity, Equity & Inclusion (DE&I)

We are an equal opportunity employer (EOE) and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.