Senior Clinical Biostatistician

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

 

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 CROs 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

 

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