Job Description
Participate and contribute to the development of new projects by providing expertise in design and statistical assumptions.
Possesses in-depth knowledge of the latest clinical research trends and developments. Demonstrates a strong understanding of the global landscape and its implications for clinical research.
Leads large projects involving complex project dynamics and ensuring alignment with strategic goals.
Improves quality assurance activities. Consistently demonstrates a high level of attention to details and documentation management.
Leads risk management activities/projects; monitors and reports on risk status and effectiveness of controls.
Oversees data analysis initiatives; develops new methodologies and tools for data management.
Participates in meetings with internal and external stakeholders, discussing and defending study designs, contributing data science expertise.
Participates and oversees the development of Study Protocols by providing statistical input and data specifications.
Designs and oversees eCRF design and structure to meet specific study requirements.
Develops and/or oversees Data Science Plans for assigned projects.
Defines or reviews randomization procedures and produces randomization lists.
Develops and reviews Statistical Analysis Plans.
Performs and/or supervises programming of tables, listings, figures, derived datasets, and statistical analyses according to timelines and quality standards.
Performs and/or supervises quality control of statistical output, including tables, listings, figures, and analyses.
Defines criteria for different analysis populations (e.g., Safety, ITT, PP) and programs their implementation.
Plans and performs statistical analyses (interim and final) as per the Study Protocol and Statistical Analysis Plan.
Validates statistical methods using techniques like goodness-of-fit tests or model checking.
Documents and validates analysis programs and files.
Manages clinical data to ensure security and confidentiality.
Produces statistical reports and assists in writing/reviewing statistical sections of study reports.
Collaborates with clinicians, researchers, operations, data management, and programmers.
Reviews and interprets analysis results for clinical study reports.
Contributes to clinical development planning and performs/reviews sample size calculations.
Participates in international multi-stakeholder advisory boards.
Contributes to departmental strategy and goals aligned with company objectives.
Requirements
* Bachelor’s degree in Life Sciences or related fields.
* Minimum 5 years of biostatistics experience, especially in oncology clinical trials, including Phase III studies.
* Experience designing Phase I-IV trials, including basket, umbrella, and adaptive designs.
* Expertise in survival analysis methods (Kaplan-Meier, Cox models, hazard ratios, landmark analysis).
* Advanced statistical methodologies, including Bayesian methods and predictive modeling in oncology.
* Experience analyzing biomarker data and precision medicine outcomes.
* Proficiency in SAS and R; familiarity with CDISC standards and dataset validation.
* Knowledge of clinical data management tools and Python for analysis and machine learning.
* Strong understanding of ICH-GCP, FDA, EMA regulations, and oncology-specific guidelines.
* Experience preparing and defending statistical packages for regulatory submissions and participating in regulatory meetings.
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