Head of Department- Bio statistics - Top Lifesciences CRO

Location

Mumbai

Industry

Pharmaceutical & Healthcare

Contract Type

Permanent

Published

Contact

Reference

29-13-8272

Academic title

Bachelor of Science

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Job description

Operation responsibilities

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).

Requirements

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.
To perform / review Sample Size Calculations performed by Senior Statistician.
To assess key processes followed within department e.g. Randomization and Blinding process.
To review all information related to Statistics provided by Senior Statistician during protocol writing.
To review and approve key documents related to Biostatistics.
Tracking project status and assisting the team to meet the timelines.
To provide ongoing project status to the Director-Operations and areas of improvement needed in the Biostatistics with respect to team and system management.
To ensure files are set and up to date for all projects with respect to the audit readiness.
To supervise and co-ordinates the activities of a team to ensure that all Biostatistics activities are carried out in accordance with SOPs.
Responsible for development and standardization of appropriate SAS programs by maintaining Library of Programs
To review the statistical analysis performed to ensure quality output and integrity of data and analysis if any data issues are detected during statistical analysis.
To ensure the appropriate filing of the project related key documents and archival of the same on completion of Biostatistics activity for that project.
Accountable for quality output of the Biostatistics process.
Accountable for Process improvement in Biostatistics department.

Personnel Management:

Preparing and implementing training plans and is Responsible for overall training within Biostatistics Department.
To impart training on induction programme of company and to train on Standard Operating Procedures of Biostatistics as well as do study specific training if required.
To provide hands-on training on Statistical Analysis Software.
To identify need to improve quality work of Biostatistics process and accordingly conduct the additional training sessions for the team.
To do performance appraisal as per company policy.

General responsibilities:

Undertake any other responsibility, which may be reasonably allocated by designated supervisor.

Benefits

Excellent Compensation

Global Exposure
Visible Career Path
General Shift
5 Days Work

Other notes

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