Senior Manager, Biostatistics

The Senior Manager, Biostatistics - Neuroscience will be expected to work independently with minimal supervision, serving as study statistician for clinical studies. The study statistician will be accountable for supporting protocol development and study initiation, developing SAP, TLG shells, specification of variable derivation, SQS plan and DMC charter, providing statistical and validation support for analysis datasets, statistical TLGs, performing and validating statistical analysis, independently reviewing CSRs and performing data interpretation, supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of new analysis required for responses, and managing CROs. The immediate need is to support Phase II and III studies within the Neurology Business Group.

Qualifications

PhD strongly preferred, but combination of education and experience may be considered in lieu of PhD

Experience in clinical development biostatistics methods and processes in industry setting required

Functional Technical Competency in the following:

Clinical Development

Plan Creation

Statistical

Analysis

Statistical Programming

Regulatory Process for Biostatistics

Business Knowledge

Therapeutic Area Knowledge

Regulatory Knowledge

Project and Resource Management

Compliance

Additional Information

we do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

DIRECT # - 732-844-8724|

LinkedIn: https://in.linkedin.com/in/seemachawhan

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