GSK
Pharmaceutical
PrincipalStatistician
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“Principal Statistician at GSK. Skills: Biostatistics, Clinical trials, Statistical methodologies. Support statistical delivery of clinical research programmes. Undertake biostatistical activities”
What You'll Achieve.
Make new innovative drugs available; Drive disease-aligned decision-making; Enable smart decision making; Be ambitious for patients; Deliver to demanding deadlines
Industry & Context.
Business problems
What They're Looking For.
Must Have
Degree in Statistics, 3+ years’ experience as statistician, Experience in randomized clinical trials, Pharmaceutical industry experience, Business level English, Fluent level Japanese
Nice to Have
PhD or equivalent in Statistics, Experience with clinical trial statistical methodologies, Interest in life sciences research, Familiarity with regulatory interactions, Familiarity with phases of drug development, Hands-on experience with AI-tools, Experience applying creative thinking, Capable of applying innovative statistical thinking, Proven ability to deliver to demanding deadlines
What You'll Do.
Support statistical delivery of clinical research programmes
Undertake biostatistical activities
Participate in discussions with regulatory agencies
Provide input on clinical trial designs
Provide expert advice on statistical methodologies
Be an active member of development teams
Take responsibility for biostatistical activities
Collaborate with global project statisticians
Identify opportunities to align trial designs
Develop knowledge in regulatory submissions
Oversight external statistical consultants
Ensure quality is met
Keep costs under control
Represent Biostatistics at scientific meetings
Influence planning discussions
Influence decision-making
Influence strategy discussions
Ensure state-of-the-art expertise
Ensure operational excellence
Ensure statistical aspects of local study execution
Ensure Japan subgroup specific aspects of filing
Ensure Japan subgroup specific aspects of submissions
How You'll Work.
Team & Collaboration
Japan medicine development matrix teams; Global project statisticians
Communication Scope
Scientific presentations; Influencing skills
Process & Methodology
Time management
Full 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’ exper
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