Associate Director, Biostatistics 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 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 lead/oversight biostatistical activities undertaken by medicine development matrix teams including operational and strategic discussions with regulatory agencies in Japan, covering aspects such as novel clinical trial designs and innovative statistical methodologies, including Bayesian techniques, to enable smart decision making and be ambitious for our patients. Key Responsibilities Lead Japan clinical development biostatistics strategy for multiple indications/projects potentially across multiple therapy areas Partner with matrix teams in Japan, including collaboration across the Asia and global development organizations to drive asset development 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, including Japan specific requirements, and act as local subject matter expert on statistical aspects of regulatory submissions in Japan across at least one therapy area Serve as statistical expert for internal and external collaborators, investigators, consultants, and contract resources Represent GSK Asia R&D Biostatistics at scientific meetings and presentations Influence planning and decision-making strategy on the GSK Japan portfolio of assets through building and maintaining effective business relationships with key functions 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 5+ 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 is highly desirable Experience with clinical trial statistical methodologies, either emerging or implemented, to maximize program success in at least one therapy area of: Respiratory, Inflammation and Immunology (RII); Vaccines/Infectious Disease (Vx/ID); or Oncology. RII or Vx/ID preferred. Extensive knowledge of at least one therapy area: Respiratory, Inflammation and Immunology (RII); Vaccines/Infectious Disease (Vx/ID); or Oncology. RII or Vx/ID preferred. Familiarity with regulatory interactions and pathways Track record of strong statistical contributions and accomplishments in clinical drug development, with a broad knowledge of all phases of drug development (pre-clinical; Phase I-IV). Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence. 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