Statistical Programmer

JOB SUMMARY Summarize the primary purpose & key accountabilities of the job.
· A productive, hands on programmer who applies technical knowledge and practical experience to
· deliver statistical programming deliverables to support assets and study teams with limited supervision early in role and independently later in role
· Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible
· Ensures adherence to high quality programming standards in their daily work
JOB RESPONSIBILITIES
· Indicate the primary responsibilities critical to the job.
· Accountable for the quality and timely delivery of datasets and displays required for their clinical study.
· Reports as well as other asset level deliverables they may be programming
· Ensures appropriate documentation and QC across the lifespan of the study for all of their · programming deliverables
· Exhibits routine and occasionally complex problem-solving skills, seeking direction when appropriate.
· Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place.
· Will be knowledgeable in core safety standards as well as TA standards pertinent to their project, may · aid in development of standards necessary for their study
· May contribute to department level initiatives.
QUALIFICATIONS / SKILLS Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills
Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
· At least 5 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
· Statistical Programming and SAS hand-on experience
· Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.
· Good understanding of ICH and regulatory guidelines
· Working knowledge of clinical data and relevant data standards
· Strong written and oral communication skills, and project management skills
· Proven ability to operate with limited oversight
· Knowledge of at least 1 Therapeutic Area
· Proven ability to manage delivery under tight timelines.
· CDISC experience desirable

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