Associate Director, Biostatistics

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers.

Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission.

Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.

By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.

Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients.

Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy.

We invite you to join us.  

Hybrid

Employee Value Proposition: 

A​t Taiho Oncology, our compassion for patients extends to every member of our team, empowering and motivating you to excel in your role.

This role offers an exciting opportunity to join a diverse and talented group committed to advancing oncology treatments.

You'll experience multiple facets of biostatistics within a dynamic, collaborative, and global environment, working alongside dedicated professionals who share a common goal of transforming patient care.

We are dedicated to not only advancing treatment but also fostering an inclusive and supportive workplace where every employee can thrive. 

Position Summary: 


* This position will have direct responsibility including clinical trial design and execution, analysis and reporting of data, and authoring/review of scientific and regulatory documents.  The Associate Director of Biostatistics will have CRO oversight, management of statistical projects, and the ability to work cross functionally with other departments. 

Performance Objectives:


* Design clinical trials including randomization, sample size calculation, interim analyses, etc., for both early and late phases


* Develop and finalize statistical sections of clinical protocols and statistical analysis plans (SAPs).


* Generate and review TFLs for the clinical trials


* Analyze and help interpret clinical data


* Create/author statistical sections of scientific and/or regulatory documents


* Manage external biostatisticians to ensure quality performance, validate and QC CRO’s deliverables


* Manage activities associated with IB updates, DSUR, PSUR and other required reports


* Perform other statistical analyses or duties as required (e.g., Interim analysis, Meta-analysis etc.)


* Keeps management current on project status and provides ongoing risk assessments


* Work with team to develop CDISC submission package to regulatory agency inclu...