"Alerted.org

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:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

Reporting to the Senior Manager of Statistics, the Senior Biostatistician will take part and lead work across the various domains of our clinical development, including trial design, data analyses for regulatory submissions and scientific publications, and will play an essential role in multi-disciplinary project and study teams. The Senior Biostatistician will have close interaction with the various steering committees for Abiomed sponsored prospective randomized studies and registries.

Responsibilities:

+ Contribute to the strategic and statistical thinking for product and study team initiative support

+ Develop trial and study design options and provide statistical guidance for on-going and planned clinical studies / trials

+ Develop statistical sections of clinical study documents, such as clinical protocols/synopses, SAPs, mock TLF shells with mapping and trial/study summary reports

+ Conduct statistical simulations for evaluating and developing novel _a priori_ and interim clinical trial designs and sensitivity analyses

+ Participate in the planning, design, development, and execution of clinical protocols

+ Support EDC design and perform statistical edit checks of source data

+ Validate clinical study report, annual report, and compliance statistical outputs according to SAP requirements

+ Lead and support data analyses to enable generation of clinical evidence manuscripts

+ Provide validation and review services for peer statistician’s work and external projects. Write up and communicate findings as necessary

+ Maintain archives of study data and relevant programming documentation

+ Participate in the development of internal guidelines and Standard Operating Procedures

+ Prepare project updates for weekly/monthly status meetings

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

Qualifications:

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

+ Minimum of five years of clinical research experience in medical device, pharmaceutical, biotech and/or CRO industries

+ Extensive experience in clinical trial design, data analysis and interpretation, as well as regulatory interaction and/or submission

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

+ Extensive experience in the design and programmatic navigation of clinical databases

+ Extensive experience in working collaboratively with others in a team environment

+ Strong interpersonal skill, oral and written communication skills

The anticipated base pay range for this position is $146,200 to $197,800.

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)).

+ 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.

\#LIRemote

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: