Vacancy expired!
Roles & Responsibilities:
- Confidently displays excellent internal and external customer service
- Responsible for implementation and execution of high quality clinical programming
- Demonstrates strong understanding of ICH guidelines, as applicable to clinical programming
- Creates and presents programming training exercises, trains new programmers, and serves as mentor
- Utilizes System Development Life Cycle (SDLC) for programming deliverables
- Trains via self-study and self-practice independently and explores advanced topics related to programming and/or drug development
- Interacts directly and independently with client to coordinate all facets of the project; highly competent communicator with excellent client interaction skills
- Provides high level of support to the statisticians and medical writers on all programming matters according to client requirements
- Works with statisticians to provide definitions, documentation and review of derived variables needed to produce planned tables, listings, and graphs
- Generates tables, listings, and graphs from clinical trial databases using SAS
- Develops programs, verifies, validates, and maintains clinical trial databases and data entry screen using SAS and related software
- Develops data and programming specifications jointly with other programmers and biostatisticians
- Designs specific data presentations including creative summary tables, graphs, and patient listings
- Assists with preparing data validation plan based on customer needs
- Reviews data management guidelines for computer edit/validation checks
- Independently implements and validates QC findings in compliance with the NC Handling Procedure
- Conducts thorough self-reviews of deliverables prior to release to client; serves as high level reviewer for others
- Follows processes related to project management as appropriate for programming projects (e.g. updating VeoProject, updating PSS, close-out procedures etc)
- Demonstrates extensive knowledge of departmental processes (e.g. competency in programming software and willingness to share information)
- Takes initiative to suggest and implement programming process improvements and follows through to completion
- Leads most projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client
- Demonstrates excellent internal and external leadership skills for projects
- Fully accountable for providing highest quality deliverables of entire project to satisfy or exceed client requirements
- May produce and present external company presentations providing industry visibility for the organization
- Accountable for timelines, as well as, internal team interactions
- Complies with Document Control Procedure
- Complies with Record Control Procedure
- Ensures compliance to applicable ISMS policies and procedures
- Preferably a minimum of 6 years experience in the Clinical Research/Statistical Programming Environment
- College graduate in computer science or related field, or related experience
- Has high level knowledge of drug development as it pertains to programming; has the ability to apply drug development knowledge during production of high quality programs
- Extensive hands-on experience with clinical trials and pharmaceutical development
- Strong experience with data and production of TLGs
- Strong programming and logic skills
- Thorough understanding of CDISC standards and HL-7 standards
- Extensive experience in pharmaceutical or CRO industry preferred
- Strong SAS programming, SAS Base, SAS Macro experience
- Thorough knowledge of clinical database structures
- Ability to program data presentations, using program such as SAS procedures
- Subject matter expert for SAS programming skills; willing to guide others in a variety of programming techniques
- Strong proficiency with MS Office applications
- Excellent organizational and communication skills
Vacancy expired!