Associate Director - Biostatistics

Summary

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, 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 innovative 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.

Core Competencies & Responsibilities

Discovery & Translational

• Provides experimental design, analysis, interpretation, and statistical communications support.
• Ensures application of appropriate statistical methods and generation of accurate and reproducible results.
• Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.
• Documents projects in sufficient detail for reproducibility.
• Serves as initial consultation contact for new projects. Maintains and grows customer base and builds loyal relationships with customers.
• Assumes independent, professional responsibility for all phases of a project request from beginning through completion.
• Manages multiple projects.
• Leads Statistical Input for at least one functional area, research field, or compound.
• Provides input to product development and performs statistical functions for submission related activities where appropriate.
• Regularly presents at external conferences, and meetings and advisory boards when necessary.
• Partners with other statisticians in developing publications (e.g. manuscripts, oral presentations, posters, abstracts, and internal technical reports) and creating software.
• Develops methodologies for the use of emerging technologies.
• Contributes to the advancement of statistical methodology through publications.
• Contributes to the advancement of software though software development.
• Represents the company by making presentations to industry conferences and associations.
• Identifies and collaborates with experts and external partners to achieve results for project specific needs.

Statistical Modeling & Methodology

• Support broad implementation of innovative statistical approaches across the development portfolio. Help identify potential hurdles for broader use of innovation in drug development and finding solutions for them.
• Support development and implementation of innovative approaches, participating in their hands-on implementation through direct interactions with statisticians. This involves, but is not limited to, identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods under a range of scenarios; and participating in the implementation of the selected approaches by engaging in protocol and SAP write-up.
• Collaborate with external consultants to provide support in the development and implementation of innovative methods and designs.
• Identify opportunities for innovation, participate in program reviews/discussions; interact directly with statisticians and other QS scientists for early identification of opportunities for innovative approaches.
• Collaborate in talent identification, hiring and development for SMM group.
• Help identify, organize, provide and/or arrange training and presentations on innovative approaches across the R&D organization (including statisticians, pharmacometricians, clinicians, and other stakeholder groups) to ensure 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.
• Engage 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.

Manufacturing & Toxicology

• Provides experimental design, analysis, interpretation, and statistical communications support.
• Ensures application of appropriate statistical methods and generation of accurate and reproducible results.
• Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.
• Documents projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories.
• Serves as initial consultation contact for new projects. Maintains and grows customer base and builds loyal relationships with customers.
• Assumes independent, professional responsibility for all phases of a project request from beginning through completion.
• Manages multiple projects.
• Supervises contractors/special assignment personnel/interns/co-ops as required.
• Leads Statistical Input for at least one functional area, research field, or compound.
• Provides input to product development and performs statistical functions for submission related activities where appropriate.
• Regularly presents at external conferences, and meetings and advisory boards when necessary.
• Partners with other statisticians in developing publications (e.g. manuscripts, oral presentations, posters, abstracts, and internal technical reports).
• Contributes to the advancement of statistical methodology through publications.
• Contributes to the advancement of software though software development.

Medical Affairs

• Provides critical statistical oversight to Medical Affairs clinical studies and assumes a leadership role in clinical trial and/or patient registries planning (mostly Phase 3b/4 trials or observational studies for post marketing commitments/requirements) and reporting related activities; assumes the role of a Statistics representative for cross-functional teams and works on several trials (projects) simultaneously.
• Provides 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.

Real World Evidence

• Provides analytical support to a designated Early Patient Insight and Value Output Team (ePIVOT) as they uncover patient and health system insights to shape better DAS strategies, clinical development plans, market access plans and pre-launch commercial strategies.
• Interacts 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.
• Contributes analytical support to Early Patient Insight and Value Output teams (ePIVOT) and works closely with IT and Epidemiology to access data and apply advanced analytics to address research needs related to Real World Evidence based on analysis of clinical and observational data sources.
• Aligns the efforts of Janssen R&D Operations with the Therapeutic Area Disease Area Strongholds and other stakeholders to bring analytical insights including: Identification of predictors of disease and targets for early intervention, statistical and disease area modeling to contribute to more efficient clinical trial protocols with increased probability of technical and regulatory success, utilization of real world data assets in landscape analysis in partnership with clinical pharmacology and pharmacometrics modeling staff, contribution to the efficient re-use and analysis of healthcare data to address scientific questions of interest to Janssen within the IMI framework; understanding subpopulations and outcomes to contribute to more effective clinical development planning and commercial strategies.