Principal Statistician at GSK

Job description

Job Purpose Japan plays a critical role in the growth and success of the GSK organization. This new position is created within the GSK Japan Biostatistics team, part of the wider Asia Biostatistics group. The primary responsibility of this role is to support the statistical delivery of clinical research programmes to Asian patients, making new innovative drugs and vaccines available to Japanese patients and drive disease-aligned decision-making in GSK Asia R&D. This role will undertake biostatistical activities as a member of Japan medicine development matrix teams including participation in discussions with regulatory agencies in Japan and provide input and expert advice on aspects of novel clinical trial designs and innovative statistical methodologies, including Bayesian techniques, to enable smart decision making and be ambitious for our patients. Key Responsibilities Be an active member of Japan medicine development matrix teams and take responsibility for biostatistical activities in this team for specific indications/projects Collaborate with global project statisticians to identify the opportunities 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 is met and costs are kept under control Represent GSK Asia R&D Biostatistics at scientific meetings and presentations Influence planning, decision-making and strategy discussions within the Japan medicine development matrix teams of which you are a member Ensure state-of-the-art expertise on all methodological aspects of drug development in statistics Ensure operational excellence in statistical aspects of local Japan study execution and in all Japan subgroup specific aspects of filing and submissions to Japan regulatory bodies. Basic Qualifications: 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. Preferred Experience or Qualifications: A strong sense of initiative, urgency, drive, pragmatism and judgement – overall an ability to make things happen. 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 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 Why GSK? Uniting science, technology and talent to get ahead of disease together. 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