Freelance Senior Statistical Programmer

This is a fully remote position, open to applicants in Poland.

📋 Description

• Lead and engage in the creation and validation of high-quality CDISC datasets in accordance with implementation guidelines and through consultations with sponsors, project leads, systems analysts, other programmers, and end users.

• Leverage your knowledge of data standards and regulatory requirements to facilitate discussions with clients regarding suitable database design strategies.

• Utilize study protocols, CRFs, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently draft SDTM specifications from the ground up; employ Pinnacle 21 for data conformance checks and generate define.xml for SDTM and ADaM submissions.

• Serve as the CDISC subject matter expert.

• Transform designs and specifications into computer code, analyze the code to identify error sources, and make necessary revisions to programs.

• Document changes made to computer code, programs, and specifications, ensuring they are maintained accurately.

• Evaluate user and technical documentation created by others to verify alignment with program operations.

• Provide expertise related to statistical programming and CDASH data collection throughout the study lifecycle, including review of protocols, drafting CRFs, preparing and assessing validation plans, and reviewing vendor DTAs.

• Modify and support software programs developed by others.

• Mentor and train colleagues and junior programmers in your areas of expertise.

• Ensure effective, precise, and timely communication of critical issues and progress updates to the team and senior management.

• Undertake functional lead responsibilities on assigned projects while maintaining oversight of scope and budget.

• May offer guidance and input regarding budget considerations and business proposals.

⛳️ Requirements

• BA/BS in computer science, statistics, or a related field, with a minimum of 5 years of experience in statistical programming using the SAS language within the CRO/Pharmaceutical sector.

• Extensive experience and understanding of the SDTM model, including the transformation of raw data files while adhering to CDISC standards from start to finish (raw data to eSub); advanced knowledge of the SDTM model, including specification, programming, and conformance for SDTM CDISC; strong CDISC skills with a focus on SDTM End to End submissions experience.

• Familiarity with the ADaM model, including both specification, programming, and conformance for ADaM CDISC is advantageous.

• Proficient in SAS/Base with a focus on data step programming; capable of modifying existing SAS code as well as developing new SAS code based on specifications.

• Knowledge of clinical trials and applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Experience with data/submission conformance tools (like P21), creation of define.xml, SDSP, and study data reviewer’s guides.

• Strong communication skills: Ability to demonstrate written, verbal, and presentation skills to effectively highlight the successes of your work and those of Rho.

• Commitment to Quality: Every role at Rho requires meticulous attention to detail, a comprehensive understanding of our high-quality scientific standards, and a genuine concern for every outcome.

• High-Character: Contribute positively to our collaborative culture with honesty and integrity. At Rho, we uphold a strong team spirit characterized by loyalty, accountability, and mutual respect. We work smart and hard together, share laughter, and take responsibility for our actions, forgiving honest mistakes and respecting one another.

• Critical Thinker: Rho values analytical thinking. Utilize your inherent creativity, enhanced by our knowledge, training, and experience. We assess situations and opportunities with objectivity and insight, crafting innovative and practical solutions.

• Agile and Adaptable: Rho appreciates the capacity to adjust swiftly. We proactively anticipate, respond to, and capitalize on changes in our environment. We embrace risk while managing it through careful planning and learning from both our failures and successes. The chance to adapt and evolve inspires us.

🏝️ Benefits

• Comprehensive health insurance plans.

• Retirement savings options with employer matching.

• Generous paid time off policy.

• Opportunities for professional development and continuing education.

• Collaborative and inclusive work environment.