Principal Statistician

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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。

Skills

Data Analysis, Drug Design, Research Designs, Research Reporting, Statistical Analysis  

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

This Position Description is to provide a framework for job understanding between employee and manager. It may not cover or contain the full listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice and at the discretion of the management of the Company. The position description is not used in the assignment or assessment of any GSK level or grade used in the Job Evaluation Process.

Compensation Grade:

Japan - 7A

Job Posting End Date:

Not Available

Eligible for Employee Referral Bonus:

Yes

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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