Product Director leading Customer Growth at Trainline, defining strategies for paid propositions and customer lifecycle management. Driving growth through innovative monetisation and engagement approaches.
About the role
- Lead Biostatistics activities for late-stage development of medicines at GSK. Design statistical strategies and mentor teams in a high-impact role.
Responsibilities
- Lead statistical planning and design for phase II and phase III clinical trials for medicines in development to treat MASH and ALD.
- Provide statistical approval of trial protocols, analysis plans, and regulatory submissions.
- Oversee clinical data analysis, interim reviews, and final study reporting.
- Advise cross-functional teams on strategy, risk, and interpretation of results.
- Line-manage and mentor statisticians to build capability.
- Direct experience engaging with regulatory agencies and preparing regulatory statistical documentation.
- Represent programs in senior governance meetings and external regulatory interactions.
Requirements
- MSc or equivalent in Statistics, Biostatistics, Mathematics, or related quantitative discipline.
- Significant experience in statistical support of clinical development, preferably within ALD and/or Metabolic disease in the pharmaceutical/biotech industry.
- Expertise in the design, analysis, and interpretation of clinical studies, including biomarker development.
- Demonstrated success leading and developing high-performing teams in a global environment.
- Strong track record of methodological innovation and application of advanced quantitative approaches (e.g., Bayesian methods, model-informed drug development).
- Experience influencing cross-functional teams and senior decision-makers.
- Excellent communication skills, with the ability to articulate complex statistical concepts to diverse audiences.
- Experience working with regulatory authorities and external collaborators is strongly preferred.
- PhD in Statistics, Biostatistics, or related field is preferred.
- Background in therapeutic areas relevant to MASH and ALD.
- Track record of building statistical strategy across global development programs.
- Familiarity with statistical programming in R and validated analysis environments.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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