Sr. Manager, Statistical Programming

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: 

At Taiho Oncology, Inc., our compassion to advance research and development of innovative anti-cancer therapies extends to our team, empowering each team member to work with a shared purpose to improve the quality of life for oncology patients and their families.

This is an exciting opportunity to join a diverse and highly talented team and be a part of making a meaningful difference in the lives of oncology patients.

 

Position Summary: 


* The position will be responsible for providing support and technical guidance of statistical programming to clinical project teams, managing collaborations with CROs, and implementing quality control process to ensure the integrity of statistical outputs.

Performance Objectives: 


* Effectively designs/develops SAS programs for clinical study reports, for regulatory submission, and for IB updates, DSUR, PBRER, etc.


* Develops/validates statistical regulatory submission package (CDISC, SDTM, ADaM, define document, reviewer guide etc.); Acts as an SME in regulatory filings in terms of submission data package.


* Supervises and manages CROs and resources to ensure the delivery of high-quality TLFs and meeting project timelines.


* Develops SAS programs and performs quality control checks for SAS code and outputs produced by CROs as required.


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


* Responsible for maintaining/archiving clinical database, SAS programs and results, and documentations.


* Identifies problems and develops global tools that increase the efficiency and capacity.


* Organizes or participates technical meetings including internal and external representatives.

Education/Certification Requirements: 


* Bachelor/Master's Degree in Biostatistics, Mathematics, Statistics, Computer Science, Life Science (or equivalent degree)

Knowledge, Skills, and Abilities: 
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