Responsible for managing the operations of the clinical biostatistics group such as providing statistical expertise to consider clinical development strategy, study design, data analysis and interpretation of results for clinical trials, statistical support for post‐marketing studies and life‐cycle management of launched products.
- Prioritize and assign projects, closely monitoring resource allocation and work schedule.
- Evaluate and obtain resources from functional organizations, support the group and outside sources to ensure project success.
- Mentor, coach, train and develop the direct reports, evaluate performance and provide opportunities for growth.
- Develops budget and monitors the controlling of expenditures.
- Oversee and manage the operations of the Clinical Biostatistics group:
: Ensure that statistical analysis and reporting procedures comply with relevant regulations, guidance, directives, and standards including preparation and maintenance of relevant standard operating procedures.
: Develop study documents related to statistical analysis such as study protocols and SAP (statistical analysis plan), DPS (Data Presentation Specification) etc.
: Develop statistical interpretation of study results including TLR, and review the contents of CSR, CTD and other regulatory documents.
- Provides expert statistical input to study design and analysis plans which include sample size estimation, for clinical trials, regulatory interaction, and NDA approval
- Maintains current knowledge of statistical management and regulatory areas relevant to the industry.
- Guides and oversees internal efforts to assist clinical scientists with biostatistics work, publications, and manuscripts.
- Develops good internal and external relationships with key leaders within Janssen and Johnson and Johnson, key staff in regulatory agencies, and external outsourcing partners.
- Drives the implementation of continuous process improvements while maintain sustainable efficiency in globally consistent processes, especially for processes relevant to data processing in clinical development.
- Proposal of statistical strategy/documents as a group, and/or statistical input to JCoT through CB group
- Facilitate and advice strategic & data‐oriented (quantitative) discussion by utilizing statistical thinking such as modeling & simulation approach members, in alignment with Bios director.
- Provide statistical expertise to develop persuasive/logical data interpretation for regulatory approvals in timely manner.
- Lead to implement “state‐of‐the‐art” statistical strategies and advanced methodology
- Lead the implementation of continuous process improvements while maintain sustainable efficiency in globally consistent processes, such as data standards and process standardization
- Internal; JCoT, QS‐J Matrix team, Group managers in Quantitative Science in Japan and Global, Functional leaders of global SDS including Clinical Biostatistics TA Heads, FL and CTSL and the head of SDS China
- External; PMDA, Academia, Professional societies, CRO partners
Span of Control:
- Budget: planning, propose & execution for all clinical projects
- Headcount: 4 or 5 HC in each group (i.e., Clinical Biostatistics Group 1 or Clinical Biostatistics Group 2)
- Advanced knowledge for multiple TAs/DAs as drug developer, such as ICH
guidelines, PMDA’s guidelines and development/treatment guidelines,
preferences of study design in each TA.
- Good skill and knowledge for statistical analysis, reporting and simulation not
only got methodology but also for computing/programming with R, SAS and/or another statistical package software.
- Demonstrated strong communication skills (in Japanese, in English desirable), including excellent leadership, innovative thinking, decision‐making skills and proven ability to foster team productivity and cohesiveness, act as a change agent, and adapt to rapidly changing organization and business environment.
- Good ability to work independently.
- Demonstrated good ability to work in interdisciplinary contexts outside statistics.
・ PhD in Statistical sciences or equivalent with minimum 8 years of relevant experience or, Master degree in Statistical sciences or equivalent with minimum 12 years of relevant experience, or, equivalent level of expertise and the
- The experience as a responsible biostatistician in a cross‐functional team environment, with increasing responsibility, in a pharmaceutical/Clinical R&D environment is required
Janssen Pharmaceutical K.K. (7195)