Freelance Senior Statistical Programmer

At Rho Inc, the focus is on guiding clients through clinical trial program strategies and developing high-quality marketing applications for regulatory authorities. The company values expertise and has a strong foundation in Biometrics, offering stability and career growth opportunities.

• BA/BS in computer science, statistics, or related field
• At least 5 years of statistical programming experience in SAS within the CRO/Pharmaceutical industry
• Extensive experience and understanding of SDTM model including end-to-end CDISC standards adherence
• Advanced understanding and experience with SDTM specification, programming, and conformance
• Experience with ADaM model specification, programming, and conformance is a plus
• Proficient in SAS/Base with emphasis on data step programming and modifying/writing SAS code
• Knowledge of clinical trials regulatory requirements including GCP and ICH guidelines
• Experience with data/submission conformance tools such as Pinnacle 21, creation of define.xml, SDSP, and study data reviewer’s guides
• Strong written, verbal, and presentation communication skills
• Attention to detail and commitment to high-quality scientific standards
• High character with honesty, integrity, loyalty, accountability, and mutual trust
• Critical thinker with ability to evaluate situations objectively and craft practical solutions
• Agile and adaptable to change, able to manage risk and learn from failures and successes

• Lead and participate in the development and validation of high quality CDISC datasets based on implementation guides and consultations with stakeholders
• Lead discussions with clients about database design using expertise in data standards and regulatory requirements
• Author SDTM specifications from scratch using study protocol, CRF, Data Transfer Agreements, CDISC CT, TAUGS, and implementation guides
• Use Pinnacle 21 to run data conformance and create define.xml for SDTM and ADaM submissions
• Act as the CDISC subject matter expert
• Convert designs and specifications into computer code, analyze code for errors, and revise programs
• Write and maintain documentation of changes to code, programs, and specifications
• Review user and technical documentation for consistency with program operations
• Provide expertise relevant to statistical programming and CDASH data collection for study phases
• Modify and maintain software programs written by others
• Provide mentorship and training to peers and junior programmers
• Communicate key issues and progress effectively to the team and senior management
• Perform functional lead activities on assigned projects including scope and budget oversight
• Provide guidance and input to budgets and business submissions of proposals

This is a freelance role for approximately 9 months at 1.0 FTE. The role can be fully remote in Poland.