The Sr. Statistical Programmer will convert data from specifications and statements of problems to computer code. The person in this role will consult with sponsors, project leads systems analysts, other programmers, and end users to gather information about program intent, functions, features, data requirements, input requirements, output requirements, internal and external checks and controls, hardware and operating system environment, and interfaces with other systems.
Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users
Use expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design
Incorporate study protocol and SAP into specifications for conversions to CDSIC
Convert designs and specifications into computer code
Analyze code to find causes of errors and revise programs
Write and maintain documentation of changes to computer code, programs, and specifications
Review user and technical documentation written by others to confirm consistency with program operations
Revise program for corrections, enhancements, or system environment changes.
Coordinate with other programmers or statisticians about program revisions
Modify and maintain software programs written by others
Provide mentorship and training to peers and more junior programmers in areas of expertise
Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management
Perform functional lead activities on assigned projects
May serve as the Project Lead on assigned projects
May provide guidance and input to the budgets and business submissions of proposals
BA/BS in computer science, statistics, or related field
A minimum of 5 years performing statistical programming in the SAS language within the CRO/Pharmaceutical industry
Extensive experience with SDTM model including transforming raw data files while adhering to CDISC standards
Understanding of ADaM model and experience with both specification, programming, and conformance of ADaM CDISC is a plus
Strong SAS/Base knowledge with an emphasis on data step programming is a must
Strong data analysis skills are required
Must be competent and comfortable at understanding and modifying pre-existing SAS code, as well as writing SAS code from specs
Understanding of clinical trials including knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Experience with data/submission conformance tools (such as P21), creation of define.xml, SDSP, and study data reviewer’s guides
Ability to provide support and/or leadership to multiple projects across a variety of therapeutic areas with minimal oversight
Must be able to establish and maintain effective working relationships with other statistical programmers as well as project team members in other functional areas in a highly collaborative environment.
Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company
Ability to handle multiple projects and priorities with exceptional organizational and time management skills
Experience interacting with sponsors is a plus
Changing what it means to work with a CRO.
At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities.
Our experts take clients beyond procedural operations and into truly proactive problem-solving. Through a collaborative approach and individualized attention, our focus is advancing your program so that together, we can help heal the world.
That is what drives us.