This Senior Level Statistical Programmer will be a leader amongst the programming and biostatistics staff. Company has numerous marketed products and a rich pipeline. We seek a highly skilled and knowledgeable industry programmer who thrives in a collaborative, empowered and dynamic setting.
Specific tasks will include:
§ Program, validate, maintain, and document statistical analysis programs for clinical trials
§ Ensure that submission and trial datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation are compliant and of the highest quality standards
§ Collaborate with colleagues in other depts. to gather appropriate requirements and ensure deliverables meet these requirements
§ Ensure smart and efficient operational planning and execution
Selected candidate will offer BS degree (advanced degree is a plus) and 4+ years of Phase I-IV pharmaceutical industry statistical programming experience. Broad and deep understanding of the drug development cycle and processes as well as the related regulatory requirements will be essential. Specific technical requirements include:
§ Expert SAS Programming skills, including expert level DATA step, SQL and macro development and Output Delivery System (ODS).
§ Expert knowledge and demonstrated experiences with structured programming practices and principles.
§ Expert knowledge of SDTM and ADaM programming requirements and practices.
§ Advanced knowledge of statistical principles including descriptive and inferential statistical methods, survival analysis, logistic regression, validation, etc.
Company is prepared to pay a top-notch, industry-leading wage including relocation to attract and retain an excellent candidate. Please forward resume for a prompt response.