Associate Director, Biostatistics
About The Position
At Johnson & Johnson,â¯we believe health is everything. Our strength in healthcare innovation empowers us to build aâ¯world where complex diseases are prevented, treated, and cured,â¯where treatments are smarter and less invasive, andâ¯solutions are personal.â¯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.â¯Learn more at https://www.jnj.com 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.
Requirements
- 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
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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Industry
Chemical Manufacturing
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
