Senior Clinical Biostatistician - San Diego, CA | Biospace
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Senior Clinical Biostatistician

Dart NeuroScience LLC

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Location:
San Diego, CA
Posted Date:
9/12/2017
Position Type:
Full time
Job Code:
17-021 #801549
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Biostatistics, Statistics,

Job Description

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 and

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