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Associate Director/Director Statistical Science

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Associate Director/Director Statistical Science

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Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

Position Summary

The occupant of this position oversees all biostatistics activities for multiple clinical trials to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Specific responsibilities include writing and reviewing statistical section of protocols, writing and reviewing statistical analysis plans, developing table, listing and figures shells, interpreting analysis results, providing input to clinical development plans and related documents, and support other functions as Statistician.

Key Duties and Responsibilities

The occupant of this position will work closely with colleagues in Medical, Clinical Scientists, Device Development, Statistical Programming, Data Management, Clinical Operations, Project Management, Medical Writing, Safety and Regulatory, as well as external CRO partners to:

• Consult in the design and development of clinical trials to ensure compliance with regulatory requirements.
• Review protocols and prepare statistical methods sections, including sample size estimation and clinical endpoint assessments.
• Generate randomization schedules as applied.
• Develop statistical analysis plans, including the development of tables, listings and figures (TLFs) shells.
• Participate the cross-function study team, oversee all statistical related activities.
• Responsible for the statistical deliverables, manage project timelines, ensure quality while maintaining cost.
• Review study and project related documents that require statistical input, including the protocol, CRF and database design, ADaM data specifications, and protocol deviations.
• Review/validate key ADaM datasets and TFLs.
• Provide statistical support to supplemental or exploratory analyses for any internal and external ad-hoc requests.
• Prepare/review statistical sections of clinical study reports.
• Review publications, presentations, and other clinical trial data/results related documents.
• Contribute to documents submitted to Health Authorities, may participate in meetings with Health Authorities.
• Participate in Data and Analytics standardization efforts.
• Maintain effective and efficient communication both within the Statistical Science and Data and Analytics group and with the other functional groups.
• Contribute to the development and maintenance of Statistical Science quality standards, SOPs and WIs.
• Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results.
• Solve problems proactively and determine when and how to escalate issues.
  
  

• PhD or MS degree in Statistics/Biostatistics and a minimum of 5 years of relevant industry experience. PhD's degree preferred.
• Strong knowledge of industry standards, such as the FDA guidelines, ICH guidelines and CDISC.
• Ample experience with oncology clinical trials is required.
• Experience in BLA/NDA Submissions and interactions with the Health Authorities is strongly preferred.
• Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive design.
• Adequate programming skills of SAS and/or R.
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
• Excellent communication and interpersonal skills to effectively interface with others.
• Must have demonstrated ability to support multiple difficult assignments with challenging timelines.
• Must have excellent verbal and written communication skills.
• The qualified applicant must be flexible, well-organized, and can work well under pressure and prioritize.
  
  

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Biotechnology

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