Head - Biostatistics - Pharma

Designation: Head Biostatistics

Location: Hosur Rd, Bangalore

Exp: 10+ Years

Education: M.Sc Statistics, (Doctorate in Statistics highly preferred)

Responsibilities:

- Works with clinical scientists, statistical programmers, clinical operations, and other statisticians to plan clinical studies, and to analyze and interpret clinical study data.

- Participates in new drug development programs as a Subject Matter Expert (SME) in statistics area and provides statistical leadership in the design of clinical development plans.

- Responsible for production of the following study-related deliverable, either personally or by supervising one or more statisticians: appropriate sections of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and registration documents.

- Responsible for providing statistical leadership for preparation of marketing applications to FDA, EMEA or other worldwide regulatory agencies.

- Works with the department peers to develop and monitor the department strategic direction and its alignment with company strategies.

- Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.

- Monitors project progress and ensures proper resource allocation for successful project deliverable against goals and timelines.