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R&D

Director of Biostatistics and Data Management

  • 标题 Director of Biostatistics and Data Management
  • 功能 R&D
  • 子功能 Biostatistics
  • 工作地 Cincinnati, Ohio, United States; Redwood City, California, United States; Santa Clara, California, United States
  • 发布时间
  • 申请ID 2206087009W
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描述

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Director of Biostatistics and Data Management, located in Cincinnati, OH, Redwood City, CA or Santa Clara, CA.

Robotics and Digital Solutions, is part of Johnson & Johnson Med Tech. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), and Cincinnati. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes.

Overall Responsibilities

This Leader will lead a team of data managers, statisticians and/or programmers in the Medical Tech Sector. This individual will be accountable for the development and execution of statistical strategy in accordance with applicable regulations for preclinical, Clinical and Medical trials. S/he ensures data management and analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets.

Key Responsibilities:

  • Provide leadership and direction for Biostatistics, including management and mentoring of staff to provide expert statistical capability across all Robotics and Digital programs.
  • Provide leadership and oversight to Data Management and Programming on the adoption of data and programming standards
  • Develop and maintains global harmonized processes and procedures for Biostatistics according to applicable laws and regulations.
  • Accountable for the programming of statistical results for preclinical and clinical trials
  • Provide statistical direction to staff for study design, protocol development, analyses, and publication strategy.
  • Work with leadership in Clinical Affairs to set priorities, develop project management plans for trial execution including timelines, milestones, and budgets.
  • 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.
  • Provide oversight of statistical support of non-clinical and pre-clinical projects across all Robotics and Digital programs
  • Develop a data storage and management solution for Robotics and Digital datasets
  • Stay current with statistical research and the use of novel methodology in clinical trial design and analysis.

资格

Education:

  • A Bachelor’s Degree in Statistics with at least 10 years of experience in Statistics with at least 8 years of experience in clinical research within Medical Device or Pharmaceuticals and at least 3 years of experience leading statistical or data management teams.
  • A Master’s Degree in Statistics with at least 8 years of experience in Statistics with at least 8 years of experience in clinical research within Medical Device or Pharmaceuticals and at least 3 years of experience leading statistical or data management teams.

Required Skills & Experiences:

  • Demonstrated technical leadership in delivering critical milestones
  • Experience leading people across subject areas (biostats, data management, programming)
  • Experience with EDC, CTMS, eTMF and IxRS and integration of systems
  • Knowledge of GCP, CDASH/CDISC , medical coding and regulatory requirements regarding clinical data management documentation and software
  • Experience with survival analysis, longitudinal data analysis, and frequentist and bayesian adaptive designs
  • Experience interacting with regulatory agencies
  • Proficient in SAS.
  • Excellent verbal and written communication skills

Preferred Skills & Experiences:

  • Therapeutic area knowledge in at least one of urology, thoracic, or general surgery
  • Experience programming with R programming language
  • Experience with CDISC datasets, tables, listings, and figures

Other:

  • This position can be based in Cincinnati, OH, Redwood City, CA or Santa Clara, CA and requires up to 25% travel

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. 

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

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

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