Immunocore
Sr. Statistical Programmer
Immunocore, Rockville, Maryland, us, 20849
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 #J-18808-Ljbffr
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 #J-18808-Ljbffr