Sr. Manager, 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.
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Employee Value Proposition:
At Taiho Oncology, our commitment to advancing treatments in the oncology field is fueled by compassion for our patients and a deep sense of purpose. We believe that our dedication to patient care extends to our team members, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to work in a diverse, talented, and committed group of people to advance the treatment of oncology patients and experience multiple facets of biostatistics in a dynamic, collaborative, and global cross-functional environment.
Position Summary:
This position will have direct responsibility including clinical trial design and execution, analysis and reporting of data, authoring/review of scientific regulatory documents, and response to statistical issues arising from regulatory, research and early development. The Senior Manager, Biostatistics will have CRO oversight, management of statistical projects, and the ability to work cross functionally with other departments.
Performance Objectives:

• Help to design clinical trials including randomization, sample size calculation, interim analyses, primary and sensitivity analysis, handing missing data, addressing intercurrent event using Estimand strategies etc.
• Innovate and improve study design through Bayesian methods and adaptive design, including trial simulation.
• Develop statistical sections of clinical protocols and statistical analysis plans (SAPs).
• Analyze, present and help interpret clinical data results.
• Create/author statistical sections of scientific and/or regulatory documents
• Provide oversight to CROs, validate and QC their deliverables
• Support 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:

• 3 years of industry experience with PhD, 7 years with Master
• Knowledge of ICH/EME/FDA guidelines.
• Experience with oncology studies
• Excellent writing skills.
• Highly detail and quality oriented.
• A collaborative mindset.
• 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
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical form and deal with several abstract and concrete variables.
• Strong SAS programming skills, ability to use common stats software
• While performing the duties of this job, the employee is frequently required to sit, talk and hear.
• The employee is occasionally required to walk.
• The employee must utilize close vision and be able to adjust focus.
• Infrequent travel is anticipated.

The pay range for this position at commencement of employment is expected to be between $170,000 - $200,000 annually; 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, 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 PTO, 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.
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Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.
The incumbent in this position may be required to perform other duties, as assigned.
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