Job Responsibilities
1. Participate and contribute to the development of new projects by providing expertise in design and statistical assumptions.
2. Possess in-depth knowledge of the latest clinical research trends and developments, with a strong understanding of the global landscape and its implications for clinical research.
3. Lead large projects involving complex dynamics, ensuring alignment with strategic goals.
4. Improve quality assurance activities, demonstrating high attention to detail and documentation management.
5. Lead risk management activities, monitor and report on risk status, and evaluate the effectiveness of controls.
6. Oversee data analysis initiatives, develop new methodologies and tools for data management.
7. Participate in meetings with internal and external stakeholders, contributing data science expertise to study design discussions.
8. Oversee the development of Study Protocols, providing statistical input and data specifications.
9. Design and oversee eCRF design to meet study protocol requirements.
10. Develop and oversee Data Science Plans for projects.
11. Define or review randomization procedures and produce randomization lists.
12. Develop and review Statistical Analysis Plans.
13. Perform and supervise programming of tables, figures, datasets, and analyses, ensuring quality and timeliness.
14. Manage the quality control of statistical outputs, including validation of programs and files.
15. Define criteria for analysis populations and perform relevant programming.
16. Plan and conduct statistical analyses in accordance with protocols and analysis plans.
17. Document and validate analysis programs and files.
18. Manage clinical data to ensure security and confidentiality.
19. Produce statistical reports and contribute to clinical study reports.
20. Collaborate with clinicians, researchers, operations, data management, and programmers.
21. Review and interpret analysis results, contributing to clinical development plans.
22. Assist in sample size calculations and participate in international advisory boards.
23. Contribute to departmental strategy and alignment with company goals.
Requirements
1. Bachelor’s degree in Life Sciences or related fields (Biology, Biotechnology, Biomedicine, Statistics).
2. Minimum 5 years of biostatistics experience, particularly in oncology clinical trials (Phase III and beyond).
3. Experience designing Phase I-IV clinical trials, including basket, umbrella, and adaptive trials.
4. Proficiency in survival analysis methods (Kaplan-Meier, Cox models).
5. Advanced statistical methodologies, including Bayesian methods and predictive modeling.
6. Experience analyzing biomarker data and precision medicine.
7. Proficiency in SAS and R; familiarity with Python for exploratory analysis and machine learning.
8. Experience with CDISC standards and dataset validation for regulatory submissions.
9. Knowledge of clinical data management tools and ICH-GCP, FDA, EMA regulations.
10. Experience preparing and defending statistical packages for regulatory purposes.
11. Participation in regulatory meetings and response to regulatory queries.
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