Johnson & Johnson Careers
Associate Director, Statistical Sciences
Requisition ID: 1905769212W
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
The Associate Director provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence for Pre/Early/Late Development, Research & Discovery, Medical Affairs, Real World Evidence (RWE), or Manufacturing Sciences programs for research, development, and/or marketed product needs in Janssen. This position takes a leadership role in providing input to program plans. Identifies and assists in the implementation of creative statistical approaches. Represents Statistics & Decision Sciences (SDS) cross-functional and intra-departmental teams or working groups, including Janssen senior management-level reviews. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.
Discovery & Translational / Manufacturing & Toxicology
- Providing experimental design, analysis, interpretation and statistical communications support.
- Ensuring application of appropriate statistical methods and generation of accurate and reproducible results.
- Producing clear, concise, well-organized, and error-free computer programs and statistical reporting content.
- Documenting projects in sufficient detail for reproducibility.
- Serving as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers.
- Assuming independent, professional responsibility for all phases of a project request from beginning through completion.
- Leading Statistical Input for at least one functional area, research field, or compound.
- Provide input to product development and performs statistical functions for submission related activities where appropriate.
- Regularly presenting at external conferences, and meetings and advisory boards when necessary.
- Working with other statisticians in developing publications (e.g. manuscripts, oral presentations, posters, abstracts, and internal technical reports) and creating software.
- Developing methodologies for the use of emerging technologies.
- Working towards the advancement of statistical methodology through publications and software development.
- Representing the company by making presentations to industry conferences and associations.
- Identifying and collaborating with experts and external organizations to achieve results for project specific needs.
- Supporting broad implementation of innovative statistical approaches within the development portfolio. Help identifying potential hurdles for broader use of innovation in drug development and finding solutions for them.
- Supporting the implementation and development of innovative approaches, participating in their hands-on implementation through direct interactions with statisticians. This involves identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, managing, and summarizing simulation studies to evaluate the operating characteristics of alternative designs /methods under a range of scenarios; and participating implementing the selected approaches by engaging in protocol and SAP write-up.
- Finding opportunities for innovation, participate in program reviews/discussions; interact directly with statisticians and other QS scientists for early identification of opportunities for innovative approaches.
- Helping to identify, organize, provide and/or arrange training and presentations on innovative approaches across the R&D organization. Ensuring awareness and adequate knowledge about these methods. Keep up-to-date knowledge of designs and analysis methods for clinical trials, including adaptive designs, model-based methods, etc.
- Engaging in external collaborations within professional associations (e.g., ASA, IBS, SCT, ISoP, ISCB, PSI, EFPSI), participating in working groups, program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals.
- Good knowledge of biostatistics applied to clinical trials and model-based drug development.
- Experience with planning, running, and documenting simulations (including, but not limited to clinical trial simulations).
- Familiarity with Bayesian methods and inference.
- Providing critical statistical oversight to Medical Affairs clinical studies and assuming leadership in clinical trials and patient registries planning.
- Providing statistical input for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support; Contributes/leads clinical study design, analysis planning and for the development of statistical analysis plan (SAP) and data presentation plan (DPS) for MA studies; Provides input to product development and performs statistical functions for submission related activities; Provides statistical support to other disciplines related to clinical statistics (e.g., HECOR/Epidemiology and publication activities); May serve as a primary contact with outside investigators (and vendors)in the preparation of scientific presentations and manuscripts; may interact with external Key Opinion Leaders (KOLs) and pursues rigorous statistical analyses in support of business-critical new research ideas; Explores and implements innovative statistical methods; Represents department in meetings with regulatory agencies.
- Providing analytical support to a designated Early Patient Insight and Value Output Team (ePIVOT) as they uncover patient and health system insights to craft better DAS strategies, clinical development plans, market access plans and pre-launch commercial strategies.
- Interacting closely with Quantitative Sciences statisticians and modelers, and Epidemiology Analytics staff in the generation and evaluation of research questions to support ePIVOT and DAS goals and objectives.
- Contributing to analytical support for ePIVOT and works closely with IT and Epidemiology to access data and apply advanced analytics to address research needs related to RWE based on analysis of clinical and observational data sources.
Do you have the following Education and Experience requirements we are looking for?
- You are qualified to Ph.D. / MSc Statistics or related discipline
- You are proficient in SAS or R programming.
- You have Excellent written, oral, and communication skills.
- You are able to work independently.
- You have a willingness to work in interdisciplinary contexts outside statistics.
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.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)