Associate Director, Biostatistics (Information Technology)
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, 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.
- Develop and finalize statistical sections of clinical protocols and statistical analysis plans (SAPs).
- 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 including FDA and EMA
Education/Certification Requirements:
- Master/PhD in Biostatistics, Statistics, or equivalent
Knowledge, Skills, and Abilities:
- 6 years of industry experience with PhD, 10 years with Master
- Experience with oncology studies
- NDA, MAA submission
- SAS programming abilities
- Excellent writing skills.
- Highly detail and quality oriented.
- A positive attitude, flexibility and a proactive thought process.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to write speeches and articles for publication that conform to prescribed style and format.
- Ability to effectively present information to top management, public groups, and/or boards of directors.
- Ability to comprehend and apply principles of advanced statistical methodology, including adaptive design in clinical trial
- Strong SAS programming skills, ability to use common stats software
- The incumbent in this position may be required to perform other duties, as assigned.
The pay range for this position at commencement of employment is expected to be between $197,200 to $232,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#Location-Princeton,NJ #LI-Hybrid
