1. Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
2. Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
3. Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
4. Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
5. Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
6. Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
7. Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge
Education
8. • PhD or MS in Biostatistics, Statistics or related field
Experience
9. Minimum of 8 years of experience in clinical trial statistics, preferably within a pharmaceutical or CRO setting.
10. Technical Expertise:
11. Advanced proficiency in SAS / R for data analysis and statistical programming.
12. Experience with Bayesian methods, predictive modeling, and simulation techniques.
13. Proven track record in strategic study design, including adaptive designs, sample size calculations, and interim analysis planning.
14. Familiarity with regulatory guidance on statistical methodologies (e.g., FDA, EMA, PMDA).
15. Solid experience in applications of advanced statistical methodologies
16. Leading roles in regulatory submissions
17. Experience in interactions with major regulatory authorities preferred
18. Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
19. Study Design and Strategy:
20. Ability to lead statistical discussions during protocol development and study planning.
21. Skilled in defining statistical analysis plans (SAP) and developing strategic approaches for complex study designs.
22. Experience in strategy discussions involving adaptive design, go/no-go criteria, and futility analyses.
23. Collaboration and Communication:
24. Strong communication skills to effectively present statistical concepts to cross-functional teams.
25. Proven experience in collaborating with clinical and regulatory teams to align statistical strategy with overall program objectives.
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