Senior Statistical Programmer

About the role

Rho is a unique CRO that encourages curiosity, innovation, and collaboration. We are dedicated to providing a supportive and stable environment for our employees to thrive.

Responsibilities

• Design and write program specifications for CDISC conversions
• Revise programs for corrections
• Create agency-accepted eSubmission deliverables independently
• Review statistical analysis plans and study documents and provide feedback to Biostatistics
• Consult with sponsors, internal and external project leads, and other programmers
• Lead the programming team on multiple studies
• Lead and participate in the development and validation of high quality CDISC datasets
• Use expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design
• Author SDTM specifications from scratch using Pinnacle 21 for data conformance and creating define.xml for SDTM and ADaM submissions
• Convert designs and specifications into computer code and analyze code to find causes of errors and revise programs
• Maintain and update documentation of changes to computer code, programs, and specifications
• Review user and technical documentation written by others to confirm consistency with program operations
• 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 while maintaining scope and budget oversight
• May provide guidance and input to the budgets and business submissions of proposals

Requirements

• Bachelor’s degree in Computer Science, Statistics, or related field
• At least 6 years of experience performing statistical programming in the SAS language within the CRO/Pharmaceutical industry
• Extensive experience and understanding in SDTM model including transforming raw data files while adhering to CDISC standards from end to end (raw data to eSub)
• Advanced understanding of SDTM model and experience with both specification, programming, and conformance of SDTM CDISC
• Strong CDISC skills with an emphasis on SDTM End to End submissions experience
• Experience with ADaM model and experience with both specification, programming, and conformance of ADaM CDISC
• SAS/Base knowledge with an emphasis on data step programming; competency modifying pre-existing SAS code, as well as writing SAS code from specs
• Knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Data/submission conformance tools (such as P21), creation of define.xml, SDSP, and study data reviewer's guides
• Strong communicator: Demonstrated written, verbal, and presentation skills to showcase the successes of your work and Rho's
• Committed to quality: An attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome
• High-character: Contribute to our collaborative culture with honesty and integrity
• Critical thinker: Evaluate situations and opportunities objectively and craft novel, practical solutions
• Able to adapt and evolve: Embrace risk but manage it by planning, accepting, and learning from both failures and successes

Benefits

• Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life & disability insurance, and 401(k)
• Paid time off, holidays, parental leave, and bereavement leave
• Flexible work environment

Pay

The range of starting compensation (annual salary or hourly rate) for this role is $110,000-135,000 per year.

EEO

Rho is an equal opportunity employer and is committed to diversity and inclusion.