Johnson & Johnson Careers
Associate Director, Biostatistics
Raritan, New Jersey
Requisition ID: 3820181005
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines (ID), and cardiovascular and metabolic diseases (CVM).
The Associate Director provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence Early/Late Development This position takes a leadership role in providing input to program plans. Identifies and assists in the implementation of innovative statistical approaches. Represents Statistics & Decision Sciences (SDS) cross-functional and intra-departmental teams or working groups, including Janssen senior management-level reviews
The successful candidate will have an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level. Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful support of multiple programs. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies advanced statistical methodology in assigned projects, such as clinical trials, with demonstrated integrated disease/scientific/functional area understanding and health authority acceptability.
He/She will comply with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidance. Takes responsibility for the quality and timeliness of project deliverables, as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head. Follows best practices for Data Integrity.
They will have a proven track record thorough knowledge of pharmaceutical research and development strategies and execution. Is an established leader for providing SDS support to experimental design, modeling, analysis planning, analysis execution, interpretation and statistical communications. Is accountable as a point of contact leader for a specific project or program and the management of all related project/program deliverables. Is an established leader for providing input to team in terms of optimizing study or trial designs in line with study or indication level objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional knowledge. May serve on the SDS TA team led by the Global Statistical Sciences TA Head.
They will builds and manage cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations (CROs), consultants, researchers/investigators) to achieve results for project specific needs with focus on improving communication, efficiency, and productivity. Often serves a SDS point .person for those partnerships. Works cross-functionally to identify and resolve issues. Collaborates within SDS to ensure integrated delivery across all phases of drug development
They will have a working knowledge of Decision Sciences Clinical Pharmacology & Pharmacometrics, Clinical Teams (or Equivalent) and associated working groups, Statistical Programming, Medical Writing, Leaders and Scientists within Therapeutic and Functional Areas, R&D Operations, Medical Affairs, Manufacturing, Safety, Regulatory Affairs, Quality, Human Resources, Information Technology, Finance, Project Management Offi
PhD in statistics or related field is required.
A minimum of 6 years of relevant experience within the pharmaceutical industry is required.
A working knowledge of SAS or R programming is required.
United States-New Jersey-Raritan-
Janssen Research & Development, LLC. (6084)