Roles & Responsibilities:-
- To develop protocol in alignment with the development plan, providing inputs on statistical scientific and operational aspects of the planning, design and reporting of trials/experiments, and production and delivery of statistical deliverables and exploratory analyses. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Project Statistician.
- Lead statistical/numerical/analytic research by providing advice and solutions on computational aspects of the problem
- Guide the trial statistician to ensure that documents, specifications, are consistent and comply with company standards by providing input into CRF and data structures tables, listings, and figures studies.
- Assume responsibility for reporting and analysis execution for multiple studies. Responsibilities include leading statistical deliverable meetings with necessary clinical trial team members and third parties, and exploration analyses for ad-hoc analyses. Expected to provide support for publications for individual clinical trials, and scientific analytical solutions.
- Oversee Biostatistics resources and deliverables for assigned trials and therapeutic area level. If required, study teams to ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or nonclinical related activities.
- Explain statistical methodology and interpret analysis results. Provide statistical expertise to support all activities and documents.
- Maintain efficient interfaces with Sr or Jr Statistician, internal and external customers as needed.
- Take lead role to collaborate with other line functions including the clinical trial team. Explain statistical concepts in a manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
- Develop and comply with project / study standards and specifications following internal guidelines.
- Support quality control and quality audit of deliverables.
