Job Category:Clinical Development
Who We Are
Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!
The 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
• MS in Statistics or Biostatistics, PhD preferred
• 10+ yrs research-oriented experience (or equivalent relevant experience /training), including minimum of 5 yrs (for PhD) pharmaceutical industry experience providing statistical support to clinical research and development teams (7 yrs if MS)• In depth knowledge of clinical trial design and methodology, including common analysis methods
• In-depth understanding of statistics (concepts and methods)
• Experienced in determining appropriate sample sizes and statistical testing procedures for clinical studies, and in conducting statistical analyses of clinical data
• Proven ability to analyze, interpret, and summarize clinical data
• Utilize knowledge of industry standards for database and dataset design (CDISC: SDTM, and ADaM)
• Ability to effectively communicate statistical methods and statistical findings to non-statisticians
• Working knowledge of the application of PK/PD principles/relationships in clinical drug development
• Experience with regulatory submissions in the U.S., including sound working knowledge and understanding of the IND/NDA process as well as experience interacting with regulators
• Working knowledge of drug development and FDA GCP/ICH regulatory guidelines as applicable to statistics
• Advanced computer skills with experience using applicable software applications (i.e. SPSS, JMP, or Spotfire)
• Experiencein SAS programming is necessary
• Experience with Medidata Rave, BioClinica Express is a plus and experience with other EDC systems is acceptable
• Strong written and verbal communication skills, with fluency in English
• Strong interpersonal, planning, problem-solving and organization skills
• Ability to work independently, as needed
• Experience supporting all Phases I-IV of clinical research
• Experience in CNS-related (neurology and/or psychiatry) clinical research
• Experience participating in IND/NDA preparation process
• Experience with regulatory submissions outside the U.S. desirable
• Knowledge of techniques for demonstrating non-inferiority and bioequivalence desirable
DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.
Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.