Senior Clinical Biostatistician
San Diego, CA
Telephone, E-mail, Postal Address:
12278 Scripps Summit Dr.
Number of Openings:
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.
Skills / Education 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.
· 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.
Data Posted: 11/2/2017