Education: M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics)

Work Experience Required :

- Minimum 10 years of analysis and reporting experience in clinical trials of which atleast 8 years as Biostatistician.

- Minimum immediate 5 years in Managerial capacity.

Position Summary -

This role involves Leading and Managing delivery of project/s in terms of resourcing, quality, timeliness, efficiency and high technical standards for deliveries made by biostatistics group including statistical outputs produced for assigned clinical studies. In an individual role, Guides and supports the team in develoment of statistical analysis plans and programs, also contributes to interpretation of results in a clinical study report and assists management team for project level activities.

Support and assist General manager in management and tracking of projects

Technical Responsibilities :

- Leading and contributing to technical strategy for a portfolio of studies (project/TA).

- Construction and building reusable standards and templates

- Defining and creating training curriculum and global training plans.

- Guide and support team in development of statistical analysis plan including table shells.

- Guide and support team in performing statistical programming for generating tables, listings, figures for efficacy outputs.

- Conduct relevant literature search to perform appropriate statistical analysis.

- Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by the various health/regulatory authorities.

- Participate in client or regulatory audits.

- Contribute to clinical trial results- statistical interpretation and facilitate discussions on clinical relevance.

- Track & Provide status to management team on deliverables, resource utilization, productivity and quality of deliverable

- Coordinate and communicate effectively with primary contacts at Client teams to ensure satisfactory progress of project work and timely resolution of issues

- Demonstrate and promote Cognizant global value system across all interactions

- Cross functional - Proactively work with Statistical Programming, data management, Medical Writing and other functions as required to address data issues as identified during execution

Accountable for all deliverables (studies) on assigned Therapeutic Area/engagement, namely:

- Responsible for quality of delieravble for assigned portfolio/TA/Segment through expert level review/QC

- Contribute to develpoment of TA/portolfio/Segment levels processes, guidelines as required.

- Participate in task forces, initiatives etc.

- Maintain current knowledge of Biostatistics practices and developments in the industry

- Compliance - Responsible for ensuring & mentoring teams to follows relevant SoPs / guidelines for the assigned TA/Portfolio/Segment

- Improvement in productivity and identify process improvement areas

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