Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy. 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, Biostatistics will have CRO oversight, management of statistical projects, and the ability to work cross functionally with other departments.
- 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.-DMC, PK, Interim 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.
- Master/PhD in Biostatistics, Statistics, or equivalent education
- 6 years of industry experience with PhD, 10 years with Master
- Experience with oncology studies
- SAS programming abilities
Other Skills and 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.
- Ability to define problems, collect data, establish facts, 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 noise level in the work environment is usually quiet.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The incumbent in this position may be required to perform other duties, as assigned.