GSK
Biopharma
AssociateDirector,Biostatistics
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“Associate Director, Biostatistics at GSK. Skills: Biostatistics strategy, Clinical trial design, Statistical methodologies. Lead biostatistics strategy. Partner with matrix teams”
What You'll Achieve.
Make new innovative drugs available; Make new innovative vaccines available; Maximize program success
Industry & Context.
Business problems
What They're Looking For.
Must Have
Degree in Statistics, Degree in Biostatistics, Degree in Mathematics, 5+ 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, PhD or equivalent in Biostatistics, PhD or equivalent in Mathematics, Experience with clinical trial statistical methodologies, Experience in Respiratory, Experience in Inflammation, Experience in Immunology, Experience in Vaccines, Experience in Infectious Disease, Experience in Oncology, Extensive knowledge of Respiratory, Extensive knowledge of Inflammation, Extensive knowledge of Immunology, Extensive knowledge of Vaccines, Extensive knowledge of Infectious Disease, Extensive knowledge of Oncology, Familiarity with regulatory interactions, Familiarity with regulatory pathways, Track record of statistical contributions, Broad knowledge of all phases of drug development, Demonstrated ability to lead initiatives, Demonstrated ability to make major contributions, Demonstrated digital fluency, Hands-on experience with AI-tools, Experience applying creative thinking, Experience applying business analysis skills, Capable of applying innovative statistical thinking, Proven ability to deliver to demanding deadlines, Maintain highest quality
What You'll Do.
Lead biostatistics strategy
Partner with matrix teams
Collaborate with global project statisticians
Develop knowledge in global regulatory submissions
Act as local subject matter expert
Serve as statistical expert
Represent GSK Asia R&D Biostatistics
Influence planning and decision-making strategy
Build effective business relationships
Ensure state-of-the-art expertise
Ensure operational excellence
Support delivery of clinical research programmes
Drive disease-aligned decision-making
Lead biostatistical activities
Oversight biostatistical activities
Discuss with regulatory agencies
Enable smart decision making
How You'll Work.
Team & Collaboration
Matrix teams; Global development organizations; Global project statisticians; Internal collaborators; External collaborators; Key functions
Communication Scope
Scientific presentations; Business relationships; Effective communication; Influencing skills
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 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 e
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