Taiho Oncology Director, Biostatistics Princeton, New Jersey
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.
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 Director, Biostatistics will have responsibility for CRO oversight, management of statistical projects, and the ability to work cross functionally with other departments. Individual must have oncology experience.
Performance Objectives:
- Designs the statistical aspects for clinical trials and related activities (e.g.-DMC).
- Writes (as primary writer or through management of biostatistician vendor) and finalizes statistical sections of clinical protocols and respective statistical analysis plans (SAPs).
- Is a signatory for finalization of statistical section of clinical protocols, CSR etc. Analyzes and helps interpret clinical data.
- Creates/authors statistical sections of scientific and/or regulatory documents, e.g.-IND etc.
- Represents and defends protocol designs and subsequent analyses during meetings with regulatory agencies and/or IRBs.
- Supervises and manages external contracted biostatisticians to ensure quality performance and meeting of timelines (e.g.-DMC, PK, IXRS, biostatistical programming, SAP etc.).
- Keeps management current on project status and provides ongoing risk assessments.
- Helps to develop continuous improvement for Taiho biostatistical processes.
- Performs other statistical analyses or duties as required (e.g.-DMC, pK, IXRS, biostatistical programming, SAP etc.).
- Monitors CRO budgets, RFP, invoices management, scope of work etc.
- Works cross-functionally with other line functions and Taiho Japan.
- Monitors the changing regulatory requirements and participates in key industry and regulatory meetings applying knowledge as needed.
- Manages activities associated with IB updates, DSUR, PSUR and other required reports.
- Maintains and applies knowledge of computerized systems, CDISC, STDM structure, data management requirements, interpretation of guidance documents published by FDA and EMA.
- Assists Taiho Japan in harmonizing the data management and biostatistics aspects throughout all Taiho companies.
Education/Certification Requirements:
- PhD/Master in Biostatistics, Statistics, or equivalent education
Knowledge, Skills, and Abilities:
- 9 years of industry experience (or equivalent clinical research experience) with PhD, 14 years with Masters.
- Experience with oncology studies Phase 1-2-3-design, all three is a plus.
- Bayesian study-design is an advantage.
- SAS programming abilities is an advantage.
- Excellent writing skills.
- Highly detail and quality oriented.
- A positive attitude, flexibility and a proactive thought process.
- Must be able to travel domestically and internationally.
- 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 theory.
- 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 computer skills in industry standard statistical programming.
The pay range for this position at commencement of employment is expected to be between $206,000 and $243,000 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.
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.
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