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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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 programming vendor

+ Manage, mentor and develop junior staff of the statistics department

+ **Qualifications:**

+ PhD or MS in Statistics, Biostatistics, Mathematics or similar area

+ Minimum of ten years of industry experience in clinical research

+ Proficient in major statistical programming languages such as SAS and R

+ Ability to work efficiently in a cross-functional team environment

+ Ability to work in a highly regulated field according to procedures, rules and SOP

+ Problem solver, pro-actively offer solutions to challenging issues

+ Excellent interpersonal skill Strong oral and written communication skill

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

\#LIRemote

Required Skills:

Preferred Skills:

Advanced Analytics, Budget Management, Compliance Management, Critical Thinking, Cross-Functional Collaboration, Data Analysis, Data Privacy Standards, Data Quality, Data Reporting, Data Savvy, Data Science, Data Visualization, Developing Others, Digital Fluency, Inclusive Leadership, Leadership, Strategic Thinking, Team Management

The anticipated base pay range for this position is :

$174250 to $235750

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.