Lead Biostatistician - Biosense Webster, Inc.

at J&J Family of Companies in Springfield, Illinois, United States

Job Description

Lead Biostatistician – Biosense Webster, Inc. – 2406202550W

Description

Biosense Webster, Inc ., part of the Johnson & Johnson family of companies, is currently recruiting for a Lead Biostatistician . The preferred location for this role is within a commutable distance of Irvine, CA however remote options will be considered on a case-by-case basis .

About Johnson & Johnson

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/.

The Lead Biostatistician will be responsible for leading statistical and analytical services in support of clinical trials, regulatory submissions, marketing efforts, and quality initiatives, as well as providing guidance on standards, processes, and technical topics within the statistics team. 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, 2 and 3 job descriptions.

§ Provide guidance on standards, processes, and technical direction within the biostatistics team.

§ Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.

§ Design and execute statistical plans independently for all phases of clinical studies, assuming a leadership role in creating strategy for study design and analyses.

§ Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.

§ Supervise generation of randomization schemes; supervise unblinding of treatment assignments and appropriate handling of unblinded information.

§ Lead 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.

§ Act as a statistical consultant to the business units and external customers on statistical issues.

§ Interface with surgeons to assist in drafting peer-reviewed journal articles.

§ Participate in vendor evaluation, selection, contracting, and oversight for statistical and programming deliverables.

§ Provide statistical reports for data quality/performance metrics.

§ Assist Clinical Research with literature reviews and other activities.

§ May assist in presenting information at professional meetings.

§ May oversee the statistical deliverables produced by lower-level biostatisticians or external consultants.

§ May oversee production of presentation materials for presentations at professional meetings.

§ Stay current with statistical methodology in clinical trial design and analysis.

The base pay range for this position is $104,000 to $166,750 based on experience . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. 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: https://www.careers.jnj.com/employee-benefits

Qualifications

EDUCATION & EXPERIENCE REQUIREMENTS :

• Minimum of a Master’s Degree in Statistics/Biostatistics or similar field is required ; PhD highly desired .

• At least 6 years of professional experience (4 with PhD) performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant area in addition to any academic experience.

• Demonstrated proficiency in SAS required . Familiarity with other statistical packages (R, SQL, Tableau, etc.) for handling smaller datasets and power analyses a plus .

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

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

• Knowledge of Bayesian statistics and meta-analyses.

• A thorough understanding of covariate analyses is required .

• Demonstrated technical experience in preparing statistical deliverables on time.

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

• Ability to contribute to strategic planning.

• Excellent verbal and written communication skills.

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

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-California-Irvine

Other Locations NA-United States

Organization Biosense Webster Inc. (6010)

Job Function Biostatistics

Req ID: 2406202550W