Key ResponsibilitiesThe role of the Sr. Statistical Programmer is to oversee and/or contribute to the delivery of the in-house deliverables including CDISC conversion; statistical programming contributions provided by Contract Research Organizations for clinical trials; to provide planned, ad hoc and exploratory statistical programming services including quality control; and to help create departmental systems, standards, and processes. This position is located onsite at our Rockville, MD office.
In close collaboration with Lead Study Biostatisticians, supporting statisticians, and clinicians; the Sr. Statistical Programmer will ensure that technical components that support the analysis, reporting, decision-making, publications, and regulatory submissions are delivered to a consistently high quality.
KEY RESPONSIBILITIESCreate or perform a review and approval of technical specification documents
o e.g. CDISC specifications, Tables, Figures and Listings (TFL) mock shellsCreate or perform a review and approval of externally delivered programming outputs, with a focus on quality
o e.g. SDTM/ADaM datasets, TFL outputsServe as a designated member of study team in the role of lead Statistical Programmer for clinical trial(s)Perform ad-hoc programming to support internal decision making
o Delivery of SDTM, ADaM datsets, Tables, Figures and ListingsProduction and quality control of datasets and output to support:Clinical study reports (CSRs)Development Safety Update Reports (DSURs)Periodic Benefit-Risk Evaluation Reports (PBRERs)Investigator Brochures (IBs), etc.Production of datasets and output to support PK/PD analysesUndertake submission planning activities, for example:Data pooling strategyProgramming input to High Level DocumentsResponse to regulatory questionsDevelop quality standards to drive efficiency and reuse of metadataDevelop a comprehensive validation process for in house programming deliverables Experience & knowledgeMathematical, Statistical, Computer Science or Life Science degree with 5+ years of relevant experience.Industry knowledgeDrug development lifecycleCDISC standardsExtensive knowledge of Health Authority requirementsSAS programming skillsBaseMacroSQLSAS GraphExperience a as lead programmerExcellent written and verbal communication skillsA proven ability to solve problems, working independently of othersExperience of alternative programming languages, e.g. R, is desirable, but not essential EducationA 4-year college degree from an accredited university. A degree or graduate in Statistics, Biostatistics, Computer Science, or related field is a plus.
QualificationsProficiency in SAS programming. SAS Certifications desirable
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