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 https://www.jnj.com

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:

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

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.

Neurovascular is part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. Neurovascular offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.

Preferred Location : Irvine, (Will consider remote work will be considered)

OVERALL RESPONSIBILITIES:

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.

POSITION DUTIES & RESPONSIBILITIES:

• 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.

Functional and Technical Competencies:

• Demonstrated technical experience in preparing statistical deliverables on time.

• Thorough understanding of descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests.

• Ability to assist in selecting and applying methods and analyses in the field of application.

• Understand the processes involved in strategic planning.

• Experience with survival analysis, longitudinal data analysis, and other current, innovative statistical methodologies.

• Excellent verbal and written communication skills.

• Knowledge of Microsoft packages; PowerPoint, Excel, Word.

• Proficient in SAS. Familiarity with other statistical packages for handling smaller datasets and power analyses.

Leadership Competencies:

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

• Performs other related duties as required.

• Strong leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead, Deliver  as noted below.

• Connect  - Manage multiple objectives from diverse stakeholders

• Shape – Develop knowledge of therapeutic areas within the Franchises and translate key insights into evidence claims or product differentiators

• Lead – Make decisions regarding the selection of statistical tests to be performed and how to present data.

• Deliver – Ensure statistical deliverables are produced on time, within budget and in compliance with regulations and SOPs

EDUCATION & EXPERIENCE 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 and 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is :

$89,000 - $146,750

Additional Description for Pay Transparency:

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 – Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.