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About the Role

Provide statistical input, write statistical analysis plans, and perform statistical analyses for routine protocol development and for safety and efficacy summaries for regulatory submissions. Participate in departmental standardization efforts and provide support towards statistical research.

Responsibilities

• Act as Senior Statistical SME at Global or Regional Program Team level with supervision on normal project with focused scope (Clinical/Safety, Regulatory)
• Integrate regional and global development needs
• Handle routine studies without supervision and demonstrate ability to bring innovation
• Drive statistical input for concept sheet (e.g., study design; sample size estimation for the most efficient and practical design; patient randomization) and study execution under the HOM (i.e., protocol/CRF development, integrated analysis plan, quality oversight of deliveries,…) without supervision for standard studies
• Write comprehensive statistical methods sections for the clinical study report; critically review and co-author these reports ensuring the accuracy of the statistical interpretation
• Oversight of CRO when outsourcing
• For integrated safety and efficacy summaries for regulatory submissions, without direction, write statistical analysis plans and perform statistical analyses
• Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation
• With direction, develop responses to regulatory agency requests that maintain perspective and are within the appropriate context
• Understand and follow all Biostatistics Quality Documents (QDs) as well as any other relevant QDs
• Contribute to process improvement according to lean concepts and to data and reporting standards improvement
• With supervision, support business development activities: Assess current available data in light of literature; Provide statistical expertise, with scenarios, in terms of compound development to registration
• Contribute to Japan strategy discussion and ensure regional strategy and requirements appropriately incorporated into IEP, IAP and other relevant plans
• Lead/Drive filings in Japan (e.g. CTN, NDA, …)
• Lead/Support interaction with Japanese HAs/KOLs
• Support Japan-specific programmer’s tasks as needed (e.g. e-data submission in Japan, analysis for local data, translation into Japanese …)
• Provide statistical support to Japan MA

Requirements

• Ph.D. or MS in Statistics, Biostatistics or related discipline
• Comfortable in Business English and Japanese
• 5-8 years' experience in the Pharmaceutical/Biotechnology industry in clinical development
• At least three years’ experience in SAS or R programming
• Understanding of ICH/GCP; Able to retrieve and understand other relevant regulations
• Understanding of Japanese regulations and standards

Skills

• SAS programming
• R programming

Location

• Japan

Work Type

• Full-time

Experience Level

• 5-8 years

Education Level

• Ph.D.
• MS

About the Company

• At Merck, we are driven by curiosity and a passion for science and technology to create innovative solutions in Healthcare, Life Science, and Electronics.
• Our solutions enrich people's lives and contribute to a sustainable world.
• We are a diverse group of curious people with varied backgrounds, perspectives, and life experiences.
• We believe this diversity drives excellence and innovation, strengthening our leadership in science and technology.
• We are committed to creating access and opportunities for everyone to grow and develop at their own pace.
• Join us to build an inclusive and belonging culture that impacts millions and enables everyone to support human progress!