Director, Clinical Data Science

Director, Clinical Data Science

The Director, Clinical Data Science will lead a team of statisticians and data managers in the Johnson & Johnson MedTech Neurovascular business. This individual will be accountable for the development and execution of statistical strategy in accordance with applicable regulations for pre- and post market clinical trials across Johnson & Johnson MedTech Neurovascular in addition to preclinical trials. S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. In addition, this individual is responsible for overseeing the execution of data management processes of new and ongoing clinical trials from startup through study maintenance and close-out phase in line with Company SOPs and best practices, reporting and escalating to senior staff as appropriate.

Location: Preferred job location: Irvine, California. Remote candidates will be considered on a case-by-case basis.

Key Responsibilities:

• Provide leadership and direction for Biostatistics, Programming and Data Management including management and mentoring of staff to provide expert statistical and data management capability
• Develop and maintain global harmonized processes and procedures for Biostatistics, Programming and Data Management according to applicable laws and regulations
• Provide statistical direction to staff for study design, protocol development, analyses and publication strategy for both preclinical and clinical trials
• Work with BPDM partners, and leadership in Clinical to set priorities, develop project management plans for trial execution including timelines, milestones, and budgets
• Provide leadership to Clinical Data Management and Programming and ensure adoption of appropriate data and programming standards
• Lead vendor evaluation, selection, contracting, and oversight activities for Biostatistics, Programming and Data Management
• Interact with regulatory agencies to support the review process of statistical methodology employed in clinical trials
• Stay current with statistical research and the use of novel methodology in clinical trial design and analysis
• Provide oversight of data management services for a portfolio of studies from study start-up through close-out, ensuring Data Management team executes against project plans
• Provide oversight of data management processes for clinical trials
• Supervise, train, mentor, and develop Data Management team
• Drive process improvements, implement corporate goals and objectives, ensure Data Management and Programming can meet the needs of the business

Desired Skills and Experience:

• A PhD in Statistics with at least 8 years of experience in clinical research within Medical Device or Pharmaceuticals is required.
• A minimum of 3 years of experience leading statistical teams is required.
• Therapeutic area knowledge in neurovascular preferred.
• Demonstrated technical leadership in delivering critical milestones required.
• Experience with survival analysis, longitudinal data analysis, and frequentist and bayesian adaptive designs preferred.
• Excellent verbal and written communication skills required.
• Experience interacting with regulatory agencies required.
• Experience programming with SAS or R required.

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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $160,000 - $276,000. 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 Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.