Associate Director, Biostatistics - MedTech Surgery
About The Position
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. About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for an Associate Director, Biostatistics to support our MedTech Surgery group. Remote work options within the United States may be considered on a case-by-case basis and if approved by the Company. The Associate Director Biostatistics will lead a team of statisticians for J&J MedTech Surgery. 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. They ensure statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets.
Requirements
- Minimum of Master’s degree in Statistics or related field of study required; 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 manging direct report FTEs required.
- Experience interacting with regulatory agencies required.
- Experience with frequentist and bayesian adaptive designs highly desirable.
- Proficient in SAS and R/Python programming.
- Demonstrated technical leadership in delivering critical milestones.
- Excellent verbal and written communication skills.
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.
Benefits
- 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)).
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
5,001-10,000 employees
