Clin DS - Senior Biostatistician

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

The Senior Biostatistician will be responsible for designing statistical analysis plans for clinical studies; performing statistical analyses independently; creating reports intended for internal distribution and for regulatory submission; creating internal presentations and white papers; and interfacing with surgeons to assist in drafting peer-reviewed journal articles. His/her work will follow guidance from Biostatistics management, and will adhere to applicable regulations for pre- and post market clinical trials. S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. Reporting to the Biostatistics Manager.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Clin DS Senior Biostatistician.

Purpose: Developing individual contributor who supports research efforts in an area of Biostatistics. Typical entry point for Master's degree in Statistics or equivalent experience.

You will be responsible for:

• Be capable of performing the responsibilities outlined in the Biostatistician 1 and 2 job descriptions.
• Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
• Design and execute statistical plans for all phases of clinical studies of moderate complexity under limited supervision.
• Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
• Generate randomization schemes; unblind treatment assignments and handle unblinded information appropriately.
• Support the review and assessment of protocol deviations to the extent that they affect statistical analyses.
• Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.
• Contribute to peer-reviewed articles independently, in coordination with the lead author/physician.
• Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology.
• Assist with preparation of documentation for IRB/Ethics Committee submissions (e.g., statistical power analysis).
• Assist in the preparation and documentation of results to support trial reports and publications.
• Resolve complex statistical issues from business units and external customers.
• Provide statistical reports for data quality/performance metrics.
• Assist Clinical Research with literature reviews and other activities.
• May assist in preparing information and materials for presentation at professional meetings.
• Stay current with statistical methodology in clinical trial design and analysis.

Qualifications / Requirements:

• A Master’s degree or Ph.D in Statistics.
• At least 4 years of experience (or Ph.D. with 2 years) performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant area.

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.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

Required Skills:

Preferred Skills:

Advanced Analytics, Analytical Reasoning, Biological Sciences, Biostatistics, Clinical Trials, Data Modeling, Data Privacy Standards, Data Quality, Data Savvy, Detail-Oriented, Good Clinical Practice (GCP), Report Writing, Research Ethics, Researching, Statistical Analysis Systems (SAS) Programming, Statistics, Technologically Savvy

The anticipated base pay range for this position is :

$92,000.00 - $148,350.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are 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.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

About Us

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/.

Privacy

Do Not Sell or Share My Personal Information

Limit the Use of My Personal Information