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Job Requirements of Sr. Statistical Programmer:
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Employment Type:
Full-Time
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Location:
Rockville, MD (Onsite)
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Sr. Statistical Programmer
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
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Recommended Skills
- Biology
- Biostatistics
- Clinical Study Reports
- Clinical Trials
- Decision Making
- Drug Development
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