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About the Role
This role supports the statistical delivery of clinical research programs to Asian patients, aiming to make new innovative drugs and vaccines available to Japanese patients and drive disease-aligned decision-making in GSK Asia R&D. The position involves undertaking biostatistical activities within Japan medicine development matrix teams, including interactions with regulatory agencies and providing expert advice on clinical trial designs and statistical methodologies.
Responsibilities
- Be an active member of Japan medicine development matrix teams and take responsibility for biostatistical activities for specific indications/projects.
- Collaborate with global project statisticians to align and optimize trial designs and analyses across regions.
- Develop knowledge in global regulatory submissions and Japan-specific requirements.
- Oversight external statistical consultants and vendors to ensure quality and cost control.
- Represent GSK Asia R&D Biostatistics at scientific meetings and presentations.
- Influence planning, decision-making, and strategy discussions within Japan medicine development matrix teams.
- Ensure state-of-the-art expertise on all methodological aspects of statistics in drug development.
- Ensure operational excellence in statistical aspects of local Japan study execution and in Japan subgroup specific aspects of filing and submissions to Japan regulatory bodies.
Requirements
- Degree in Statistics, Biostatistics or Mathematics
- 3+ years’ experience as a statistician working in randomized clinical trials, preferably in industry
- Pharmaceutical industry experience, including CRO or related sectors.
- Business level English and fluent level Japanese (JLPT1) in reading, writing, and speaking.
- A strong sense of initiative, urgency, drive, pragmatism and judgement
- PhD or equivalent in Statistics, Biostatistics or Mathematics
- Experience with clinical trial statistical methodologies and an interest in life sciences research and drug development
- Knowledge of at least one therapy area: Respiratory, Inflammation and Immunology (RII); Vaccines/Infectious Disease (Vx/ID); or Oncology.
- Familiarity with regulatory interactions and pathways
- Familiarity with phases of drug development (pre-clinical; Phase I-IV).
- Demonstrated digital fluency, including hands-on experience with AI-tools and how these can be used to optimize biostatistical aspects of drug development
- Experience in applying creative thinking/business analysis skills to improve or solve business problems.
- Capable of applying innovative statistical thinking.
- Self-motivated and independent worker
- Strong time management skills; able to effectively organize and manage a variety of tasks across different projects
- Good communication and influencing skills, curiosity, passion for patients
- Business Acumen - understands implications of decisions from a broad business perspective and uses this knowledge to influence decision-making in Asia R&D.
- Proven ability to deliver to demanding deadlines whilst maintaining the highest quality
Skills
- Data Analysis
- Drug Design
- Research Designs
- Research Reporting
- Statistical Analysis
Location
- Japan
Work Type
- Agile working culture
Experience Level
- 3+ years’ experience
Education Level
- Degree in Statistics, Biostatistics or Mathematics
- PhD or equivalent in Statistics, Biostatistics or Mathematics
About the Company
- GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
- We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
- We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
- We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
- Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Equal Opportunity
- We are committed to creating an inclusive workplace and providing equal opportunities for all applicants.
- If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.