Manager, Biostatistics (Oncology)

Remote, United States
Lead
Posted 4 days ago

In one line

Lead statistician role for oncology trials at a drug company, from protocol design through regulatory filing; office-based in Japan with US operations.

About the role

Remote and hybrid setup is not stated; the post sits with cross-functional clinical teams and external partners. Success means clean, consistent study outputs and submissions that hold up with health authorities.

At a glance

Pay: Not stated in the posting
Remote scope: Remote, United States
Seniority: Lead
Skills: SAS, CDISC, SDTM, ADaM
Posted: 31 Oct 2026
Last checked: 2 Nov 2026

What you will do

Act as lead statistician on one or more oncology clinical studies
Shape study design, endpoints, sample size, randomization and analysis strategy
Write and review statistical analysis plans and study protocols
Check analysis datasets and tables, listings and figures for quality and accuracy
Interpret results and present them to project teams
Help prepare clinical study reports, abstracts, publications and regulatory documents

What they look for

MS in statistics or biostatistics plus 4 years of experience, or a PhD
Solid grasp of statistical methods and how clinical trials are run
Knowledge of FDA, EMA, PMDA and ICH guidelines
Familiarity with CDISC standards, including SDTM and ADaM
Hands-on SAS programming
Record of contributing to protocols, SAPs, CSRs and submission documents

Nice to have

Oncology clinical development background
Experience with R
Work with CROs and external vendors

How Keywordise applies for you

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Alex DemoOperations AssociateManager, Biostatistics (Oncology)

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Full nameAlex Demo

Email[email protected]

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Open to working remotely?Yes, fully remote

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Questions about this job

Can I do this job remotely, and from which countries?

The posting lists it as remote for people in the United States.

What does this job pay?

The posting does not state a salary, so there is no figure to quote.

What experience is needed?

It is a lead role. The posting asks for: MS in statistics or biostatistics plus 4 years of experience, or a PhD; solid grasp of statistical methods and how clinical trials are run; knowledge of FDA, EMA, PMDA and ICH guidelines. Skills it names include SAS, CDISC, SDTM, ADaM.

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