Lead Biostatistician

Key Skills

Apache Hadoop, C Programming, C++, Data science techniques, Java Programming, Machine learning techniques, MapReduce, Python Programming, PyTorch, R Programming, Scala Programming, SQL, TensorFlow

Job Description

Ethicon, a member of Johnson & Johnson’s Family of Companies, is recruiting a Lead Biostatistician to be based out of Raritan, NJ or Cincinnati, OH.

Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopaedics, endoluminal intervention and general surgery. This includes the MONARCH® platform, a first-of-its-kind robotic technology indicated for bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung.

Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 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 worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.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. Their work will follow guidance from Biostatistics management, and will adhere to applicable regulations for pre- and post market clinical trials. They ensure statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. Reporting to the Biostatistics Manager.

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.

Leadership Competencies:

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Performs other related duties as required.
• Strong leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead, Deliver as noted below.
• Connect - Manage multiple objectives from diverse stakeholders
• Shape – Develop knowledge of therapeutic areas within the Franchises and translate key insights into evidence claims or product differentiators
• Lead – Make decisions regarding the selection of statistical tests to be performed and how to present data.
• Deliver – Ensure statistical deliverables are produced on time, within budget and in compliance with regulations and SOPs

Qualifications

• A Master’s degree in Statistics is required; a Ph.D in Statistics is preferred.
• At least 6 years of experience (or Ph.D. with 4 years) performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant area.
• Experience in Pharmaceutical or Medical Device industry required.
• Demonstrated technical experience in preparing statistical deliverables on time.
• Thorough understanding of descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests.
• Ability to assist in selecting and defining independent and dependent variables in the field of application.
• Ability to contribute to strategic planning.
• Experience with survival analysis, longitudinal data analysis, and other current, innovative statistical methodologies.
• Knowledge of Bayesian statistics and meta-analyses.
• A thorough understanding of covariate analyses is required.
• Excellent verbal and written communication skills.
• Knowledge of Microsoft packages; PowerPoint, Excel, Word.
• Proficient in SAS and R.
• Familiarity with other statistical packages for handling smaller datasets and power analyses.