Senior Statistical Programmer

JOB SUMMARY

· 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

· 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

· Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.

· At least 5-7 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.

· Statistical Programming and SAS hand-on experience ( ADAM & TLF )

· 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