Description: The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a Principal Biostatistician, to be located in Irvine, Ca. The MD CR&D COE supports clinical activities across all business units within the Johnson & Johnson Medical Device companies. The COE organization is based on three functional teams: Franchise, Operations and Biostatistics& Data Management. All three teams share accountability for the successful development and delivery of clinical evidence globally to internal and external (5Ps) stakeholders that drives innovation in surgical solutions and that optimizes the product lifecycle. Each team within CR&D COE will have primary responsibility for defined areas of clinical program development, execution and dissemination. The Principal Biostatistician will be responsible for developing strategy and designing statistical analysis plans for regulated and non-regulated studies; performing statistical analyses; creating reports intended for internal distribution and regulatory submissions; creating internal presentations and white papers; interfacing with surgeons to assist in drafting peer-reviewed journal articles; overseeing vendors and contractors; and contributing to studies that are focused on economic outcomes. His/her work will follow guidance from Biostatistics management, and will adhere to applicable regulations for pre- and post market clinical trials. S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. Reporting to the Biostatistics Leader.
The Principal Biostatistician will: • 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. • Assist in developing strategy for clinical trials and research aimed at healthcare economic issues. • Design and execute statistical plans for all phases of clinical studies independently, 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, or submissions aimed at other stakeholders where outcomes are economic in nature. • 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). • Participate in evidence generation strategy discussions with clinical and cross-functional partners. • 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. • Interpret statistical analyses and publications in preparation of new device applications to regulatory bodies. • 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 and Healthcare Economics with literature reviews and other activities. • Oversee production of presentation materials for professional meetings, and may assist in presenting information at these meetings. • Oversee the statistical deliverables produced by lower-level biostatisticians or external consultants. • Stay current with statistical methodology in clinical trial design and analysis. • Demonstrate technical experience in preparing statistical deliverables on time. • Demonstrate strong knowledge of products/therapeutic areas being evaluated. • Clarify descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests. • Assist in selecting and defining independent and dependent variables in the field of application. • Contribute to strategic planning. • Address survival analysis, longitudinal data analysis, and other current, innovative statistical methodologies. • Demonstrate knowledge of Bayesian statistics and meta-analyses. • Excellent verbal and written communication skills. • Knowledge of Microsoft packages; PowerPoint, Excel, Word. • Proficient in SAS. Familiarity with other statistical packages for handling smaller datasets and power analyses.
Qualifications: • A Master's degree in Statistics is required, PhD preferred. • At least 8 years of experience (or Ph.D. with 6 years) in clinical research is required. • Experience with Medical Device, Pharmaceuticals, or FDA is preferred. • Knowledge and a thorough understanding of covariate analyses is required. • Consistent demonstration of advanced statistical application and personal development in statistical methodology is required. • Travel up to 10% is required.
Primary Location: North America-United States-California-Irvine