Lead Biostatistician - Pharmaceuticals

Lead Biostatistician - Pharmaceuticals

- To provide Inputs / suggest improvements in the Data Validation Plan, Case Report Form (CRF) with knowledge of the analysis to find those variables that are critical in meeting the protocol's objectives, and ensures that the data validation plan is adequate to meet the requirements for analysis.

- To participate in the Project Discussion Meets and assign Roles and responsibilities within department

- To perform / supervise quality review of the data before data lock.

- Interact with IT team To keep track of quality check of any Software used in Biostatistics after installation and to ensure smooth Data Transfer

- Review / QC of documents of Biostatistics Department.

- Responsible for preparing/reviewing Standard Operating Procedures.

- Maintains up to date knowledge of organizational SOPs.

- Handling Project Enquiries regarding Biostatistics if required.

- To assess resource requirements and provide status to Director - Operations.

- To assign different project's responsibilities as per resource assessment to ensure key timelines are met for every customer.

- To establish effective communication channels with customer, Data Management Team (internal), Director-operations (internal) and Biostatistics team (internal).

- To give statistical inputs to the protocol and CRF design with respect to the objectives of the study and statistical part of the protocol if required by customer or review statistical inputs provided by Senior Statistician.