Biostatistician (HS08-79)

DescriptionJOB DESCRIPTION:The core mission of NIDA’s Division of Pharmacotherapy & Medical Consequences of Drug Abuse (DPMC) Informatics program is to support the scientific discovery (pre-clinical) and clinical evaluation of promising new anti-addiction therapies through information systems development and support of specialized applications. This person will provide statistical and reporting guidance for the clinical data repository, Executive Information System (EIS) and clinical applications. Prepares analysis plans and writes specifications for analysis files, consistency checks, tables, and figures. Communicates with clients regarding study protocol or statistical analysis issues as they arise. Key duties include the following:• Ensure accuracy of all statistical interpretation from the clinical data repository • Write statistical sections of integrated reports.• Provide expert statistical input into and review of statistical deliverables and data management deliverables.• Serve as Project Biostatistician• Act as statistical liaison to the client to identify key analysis needs• Participate in the development of statistical analysis plans • Recommend and establish standard safety and efficacy reports• Create derived datasets for secondary analysis• Keep up-to-date knowledge of statistical methodologies applicable to work for clinical trials• Provide input to SOP development• Provide weekly status reports to delivery manager on activities and issues• Analyze NIDA’s clinical trial processes and identify information needs. • Perform plausibility checks on data and take the appropriate action to resolve inconsistencies and to handle implausible values during analysis• Assist with the design and implementation of NIDA’s long-range Clinical Informatics PlanRequired Elements: • Ph.D. in biostatistics, statistics, or equivalent academic discipline with a minimum of (3) years’ experience in the statistical analysis of clinical trials or Master’s degree with a minimum of (5) years’ experience in the statistical analysis of clinical trials • Proficient in SAS programming or equivalent • Knowledge of clinical trial research, regulatory requirements (FDA, ICH, GCP), coding techniques and statistical software• Demonstrated experience in analyzing clinical data• Good interpersonal skills• Good verbal and written communication skills• Experience gathering reporting requirements from a CRO or external vendor• Ability to work independently as well as a contributing team member• Excellent listening skills and a commitment to communicate clearly, completely, and in a timely manner • Ability to organize time effectively and determine priorities • Ability to assess the effectiveness of processes and procedures and recommend improvements Desired Elements: Experience with Signal Detection DSMB Reporting Analysis of Variance (covariance) Categorical Data AnalysisOccasional travel to Rockville required