DescriptionIn this fast-growing and fast-paced organization, your expertise is needed to provide support for clinical and statistical programming activities related to multiple clinical studies.
Key Responsibilities- Assist in the review of key study-related documents produced by other functions, e.g. Statistical Analysis Plan, Case Report Forms, Data Management Plan, Database Specifications, EDC Data Structures, DMC plans and other clinical documents
- Write, test and validate SAS programs to produce analysis datasets, TLFs, to be included in reports for submission to regulatory agencies, publications and other communications as needed
- May serve as a technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical programming as needed
- Work with internal stakeholders to gather requirements and write specifications
- Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables
- Write macros for reusability
- Review and verify vendor deliverables for quality and accuracy
- Contribute to the development review of Statistical Programming policies, standard operating procedures and other controlled documents
- Interface with outsourcing partners and vendors
Education & Experience- B.S. preferably in Mathematics, statistics, computer sciences or other related field
- 5+ years of clinical trials experience in pharmaceutical or biopharmaceutical setting or equivalent
Additional Skills- Thorough knowledge of the drug development and regulatory submission cycle
- Excellent project management skills
- Excellent communication skills
- Able to work in a fast pace and agile environment
- In-depth and current knowledge of regulatory requirements and guidance
- Excellent SAS and CDISC skills
- Proficiency in MS Word, Excel, PowerPoint, and Project
