Associate Director, Biostatistics

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Job Function:
Data Analytics & Computational Sciences

Job Sub Function:
Data Science

Job Category:
People Leader

All Job Posting Locations:
Danvers, Massachusetts, United States of America

Job Description:

Abiomed is recruiting for an Associate Director of Biostatistics, located in Danvers, MA.

Remote work options will be considered on case by case basis.

Associate Director will provide statistical expertise in the design, analysis, and interpretation of clinical trial programs, regulatory submission and filings; and the generation of evidence to support publication and product commercialization.

The Associate Director of Biostatistics will play a leadership role in multi-disciplinary project and study teams and will also interact closely with various steering committees for Abiomed sponsored prospective studies and registries.

 

Responsibilities:


* Participate in strategic planning in product development and study design


* Develop trial design options and provide guidance and leadership for on-going and planned clinical studies


* Participate in planning, design, development, and execution of clinical trial protocols


* Develop statistical sections of clinical study documents, including but not limited to clinical study report, statistical analysis plan (SAP), and study synopsis/protocol


* Produce and validate statistical analyses and outputs according to SAP



* Play a lead role in hypothesis generating process and contribute to statistical methodology in manuscript preparation


* Provide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project team


* Drive the development of internal repository in statistical methodology and statistical programming


* Lead and coordinate statistical methodology research in novel trial design


* Provide statistical oversight and quality control of deliverables from statistical department


* Prepare projects updates for weekly/monthly status meetings


* Maintain up to date knowledge of statistical methodology and relevant regulatory guidance


* Lead the development and implementation of SOP, work instruction and best practice for statistics department


* Play a lead role in development of internal guidelines and SOPs for clinical operation and data management


* Oversee and manage statistics and prog...