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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!


Job Summary:

The Senior Clinical Biostatistician provides statistical 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.

• Work closely with colleagues (other Biostatisticians, Clinical Scientists, Regulatory, Data Management, Statistical Programmers, Medical Writing, Safety, and Clinical Operations)
• Review protocol and may 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
• Independently validate primary endpoints using SAS 
• Serve as project statistician for some phase 1 and/or 2 studies, Proof of Concept and exploratory studies
• Acts as the primary contact with the CRO for biostatistics related activities on assigned studies that have been outsourced
• Create or review programming specifications for analysis datasets, tables, listings, and figures as well as SDTM/ADAM specifications
• Review data collection strategies and instruments (CRFs), database design, edit check specifications, external data transfer specifications, and participate in User Acceptance Testing (UAT) as needed.
• Review and/or create 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 as needed

Qualifications/Requirements:

• MS or PhD in biostatistics or statistics and at least 7-10 years of relevant industry experience 
• Familiar with FDA and ICH guidance and regulations as they relate to biostatistics and GCPs
• Ability to write and review SAPs, TFLs and review protocol endpoints as well as give guidance to clinical scientists and clinicians on endpoints
• Experience with working with CRO’s and overseeing compliance with standards, output and adherence to statistical sections of protocol and SAP 
• Prefer familiarity with PK/PD data as it relates to clinical trials 
• Experience and ability to do hands-on exploratory analyses
• Understanding of statistical methods related to Mixed Effects Models, Categorical Analysis, Repeated Measures, Logistic Regression; simultaneous confidence intervals, multiple comparisons, multiplicity adjustment
• Experience with ADAM specifications and validation of these
• Understanding of use of stratification and ability to perform basic sample size calculations (e.g. NQuery, SAS POWER)
• Experience with missing data methods, i.e. MAR, MCAR, etc…
• In-depth experience with SAS statistical methods, SAS graphical methods for exploratory analysis and statistical programming

Preferred Experience:
• Experience with the following SAS procedures: e.g. ANOVA, GLM, NLIN, NLMIXED, GEE, MIXED, REG, TTEST, LOGISTIC, SUMMARY, REPORT, SGPLOT, SGPANEL, BOXPLOT, FREQ, MI, MIANALYZE, MIXED, MULTTEST, POWER
• Ability to monitor adherence to timelines for assigned studies in a fast paced environment
• Prefer experience with longitudinal analysis and PROs (outcomes)
• Familiarity and experience with CDISC STDM and giving input to clinical data managers on this and mapping, eCRF design/database capture to support endpoints, and clinical scientist/medical writers on summarization of TFLs for CSR. 
• Assist with and provide input into SOPs and work practices for biostatistics
• Strong team work and communication skills
• Prefer experience with CNS

Benefits:

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.

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