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POST DATE 8/27/2016
END DATE 4/13/2017
Dart NeuroScience LLC
San Diego, CA
JOB DESCRIPTIONThe Clinical Biostatistician (BS) provides overall statistical leadership, direction, and consulting to the Biostatistics, Statistical Programming, Data Management, Clinical R&D and Regulatory Affairs functions relating to the design, analysis and reporting of clinical trials in support of Phase I-IV clinical development and regulatory submission programs. This highly visible role will actively contribute to the development and progression of the DNS pipeline and will represent DNS as required before regulatory agencies and other organizations in defense of statistical methodologies and data analyses related to our products and programs. Therefore, the BS must be highly trained in statistical principles, highly knowledgeable about appropriate software and tools to perform his or her tasks, and must also have significant pharmaceutical industry experience providing a high level of statistical support for clinical drug R&D efforts.
Overall responsibility for statistical aspects of clinical protocol design and development through study report finalization, for Phase I-IV studies
Acts as the primary contact with the CRO for all biostatistics related activities on studies that have been outsourced
Work closely with colleagues (Clinical Scientists, Regulatory Scientists, Data Management, Statistical Programmers, Medical Writing, Safety, Clinical Operations) to:
o Review protocol and prepare statistical methods section(s), including sample size estimation and clinical endpoint assessments, to ensure DNS conducts well designed, efficient, cost-effective as well as statistically valid clinical trials
o Generate and/or review randomization schedule(s) to ensure there are no errors present and protocol requirements are met. Perform ongoing monitoring of actual
randomization scheme applied by IVRS/IWRS
o Design and/or review data collection strategies and instruments (CRFs), database design, edit check specifications, external data transfer specifications, and participate in User Acceptance Testing (UAT)
o Prepares and/or reviews detailed Statistical Analysis Plan (SAP) including development of well-presented mock-up displays for tables, listings, and figures (TLFs), conduct data analyses, and oversee preparation of all tables, listings, and figures [including review of work by programmers], as well as preparation of a formal statistical report (PRN)
o Create or review programming specifications for analysis datasets, tables, listings, and figures as well as SDTM/ADaM specifications
o Conduct or participate in review and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in the SAP
o Generate/review data tables/listings and coordinate data review meetings during the course of the study and prior to database lock to ensure data quality
o Assist in enabling timely database finalization/lock
o Assist in interpreting and reporting results accurately and objectively (e.g., in CSRs, registration documents, abstracts/publications) in order to substantiate efficacy and safety conclusions/claims
o Ensure use of appropriate standards to maximize global integrability and interpretability
o Ensures proper study closeout and archiving of study related materials, i.e. datasets, programs, specifications, etc.
Serve on internal data monitoring committees (DMCs) or represent the company on external DMCs
Attend Project team and regulatory meetings as required to support development activities.
Identify study-level vendor requirements and participate in the evaluation/selection of analytical vendors along with contributions to RFPs, scopes of work, contracts, and budgets. Oversee outsourced statistical activities/functions, to ensure data quality and timeliness of data outputs
Assist in preparing/reviewing clinical sections of registration documents/other key clinical documents (e.g., INDs, IND annual reports, Investigator s Brochures)
Interacts with regulatory agencies as needed and assists in preparing/communicating study results in regulatory submissions and in responding to regulatory queries
In collaboration with Clinical Operations and CDM, assist in monitoring clinical trial conduct/status
Provide statistical input into the creation of clinical development plans/strategy documents for a given asset, and/or marketing and publication strategies
Direct exploratory analyses to discover/define possible drug effects/claims; perform ad-hoc statistical activities as needed to support both internal and external requests
Support in-licensing due-diligence activities, by reviewing data/reports as needed
Participate in process improvement/development activities for standards, processes, and guidelines
Publish methodological research based on projects at DNS, as the opportunities arise