Uses R and SAS, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
Works to ensure that outputs meet quality standards and project requirements.
Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.
Keeps project team members informed of programming progress and issues requiring their attention.
Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements.
Anticipates and addresses potential programming issues, reflects forethought, establish the basis for efficient programming and accurately define all variables to be accepted by peer review and sponsor/requestor with little rework.
Conducts effective internal meetings (appropriate in format, frequency, and attendance).
Requirements
R Programming experience required
CDISC
SDTM/ADAM programming experience Required
Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
Extensive programming experience in R or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.
Knowledge and experience in the use of CDISC Standards for regulatory agency requirements
Experience in submissions to a regulatory agency preferred.
Experience in mentoring others in clinical trial process and CDISC Standards.
Excellent written and verbal communication skills.
Ability to read, write, speak and understand English.
Benefits
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.