Key Responsibilities The 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 RESPONSIBILITIES
• Create or perform a review and approval of technical specification documents
o e.g. CDISC specifications, Tables, Figures and Listings (TFL) mock shells
• Create or perform a review and approval of externally delivered programming outputs, with a focus on quality
o e.g. SDTM/ADaM datasets, TFL outputs
• Serve 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 Listings
• Production 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 analyses
• Undertake submission planning activities, for example:
• Data pooling strategy
• Programming input to High Level Documents
• Response to regulatory questions
• Develop quality standards to drive efficiency and reuse of metadata
• Develop a comprehensive validation process for in house programming deliverables
Experience & knowledge
• Mathematical, Statistical, Computer Science or Life Science degree with 5+ years of relevant experience.
• Industry knowledge
• Drug development lifecycle
• CDISC standards
• Extensive knowledge of Health Authority requirements
• SAS programming skills
• Base
• Macro
• SQL
• SAS Graph
• Experience a as lead programmer
• Excellent written and verbal communication skills
• A proven ability to solve problems, working independently of others
• Experience of alternative programming languages, e.g. R, is desirable, but not essential
Education A 4-year college degree from an accredited university. A degree or graduate in Statistics, Biostatistics, Computer Science, or related field is a plus.
Qualifications Proficiency in SAS programming. SAS Certifications desirable
Location: Rockville, MD
Posted: Sept. 26, 2024, 11:05 a.m.
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