Experience
4 - 10 yrs
Job Location
Pune, India
Vacancy
1
Designation
Biostatistics Manager
Job Type
ONSITE
Job Description
Description Principal Biostatistician (Therapeutic Areas - Oncology / Vaccines)
Job Responsibilities
- Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
- Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.
- Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
- Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required.
- May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
- Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
- Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
- Implements company objectives, and creates alternative solutions to address business and operational challenges.
- As biostatistics representative on project teams, interfaces with other departmental project team representatives
- Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
No Referrers Available
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