Ethicon , part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com .
The Associate Director Biostatistics will lead a team of statisticians in the Ethicon Franchise. 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 the Franchise. S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. The primary location for this role will be in Raritan, NJ however candidates may also reside within a commutable distance of Cincinnati, OH . This role will work a Flex/Hybird schedule. Relocation assistance is available to qualified candidates .
POSITION DUTIES & RESPONSIBILITIES:
· Provide leadership and direction for Biostatistics, including management and mentoring of staff to provide expert statistical capability
· Develop and maintains global harmonized processes and procedures for Biostatistics according to applicable laws and regulations
· Provide statistical direction to staff for study design, protocol development, analyses and publication strategy
· Work with trial team, and leadership in Clinical Operations and Franchise to set priorities, develop project management plans for trial execution including timelines, milestones, and budgets
· Provide input to Clinical Data Management and Programming leadership on the adoption of data and programming standards
· 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
The base pay range for this position is $140,000 to $230,000 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
EDUCATION & EXPERIENCE REQUIREMENTS:
· Minimum of Master’s degree in Statistics or related field of study; PhD strongly preferred
· Minimum 8+ years (6+ years with a PhD) of experience in clinical research within Medical Device and/or Pharmaceuticals sector.
· At least 3+ years of experience managing direct report FTEs.
· Proficient in SAS and R/Python programming
· Demonstrated technical leadership in delivering critical milestones
· Experience with frequentist and Bayesian adaptive designs desirable
· Excellent verbal and written communication skills
· Experience interacting with regulatory agencies required
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.