Biostatistician (Evergreen)

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

Benefits offered by this job

15 Days PTO

Paid holidays

Tuition Reimbursement up to $10,000/yr

On-Site/Hybrid/Remote Work

DEI focus

Job summary

Terumo Neuro invites applications for a Biostatistician to lead statistical analyses for clinical trials and post-market studies. This evergreen posting seeks experienced candidates with regulatory knowledge and strong collaboration across cross-functional teams.

Responsibilities include developing SAPs and CRFs, generating tables and figures in SAS, overseeing data quality, and mentoring junior staff. Travel up to 10% is expected; PhD in biostatistics and 5+ years in industry are required.

Qualifications

• PhD in biostatistics or statistics.
• Five years of statistical methods experience in pharma/biotech.
• At least one year in lead, supervisory or management responsibility.
• Excellent written and verbal communication skills.
• Proficient with MS Access, Excel, Word, PowerPoint, SharePoint, Visio and Project.

Responsibilities

• Oversee development and execution of clinical and technical training programs.
• Provide technical/statistical leadership and strategic input to clinical projects with cross-functional teams.
• Develop protocols and CRFs; defend statistics in protocol deviations affecting analyses.
• Develop SAPs for all phases of studies to ensure protocol alignment.
• Generate statistical tables, graphs, and reports using SAS for submissions and publications.
• Offer consultation to clinical and regulatory teams on statistical issues.
• Support Medical Affairs with literature reviews and related activities.
• Contribute to peer‑reviewed articles with lead author/physician.
• Complete meta-analyses of published data to support objectives.
• Lead development of data quality standards and perform QA for statistical programs.
• Develop and review SOPs for analysis of clinical study data.
• Provide statistical support to Regulatory Affairs, QA, product development, and Medical Affairs; assist with presentations.
• Stay current with statistical methodology in clinical trial design and analysis.
• Domestic/international travel up to 10%.

Skills

Statistical methods

Leadership

Communication skills

Regulatory knowledge

Education

Ph.D. in biostatistics or statistics

Tools

SAS

Oracle Clinical

R / S-Plus

UNIX

Microsoft Office (Access, Excel, Word, PowerPoint)

SharePoint

Visio

Project

Job description

This is an Evergreen Opportunity: We are always on the lookout for talented individuals to join our team! As an evergreen posting, we accept applications throughout the year. While there might not be an immediate opening, we encourage you to apply. We'll reach out with a suitable opportunity arises.

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.