Informacje o stanowisku

Overview

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

Why Rho?

• The foundation of our organization was built on Biometrics, and it continues to be a thriving focal point for our business with strong employee tenure and stability.
• We are large enough for strong stability, but small enough for you to have strong visibility and exposure to grow your career!
• Support and collaboration is everywhere – from the top down. You have plenty of artillery to be successful here.
• It’s fun and vibrant – our culture is unbeatable.
• Lastly, we do great work and our studies are properly staffed, that makes for very happy people!

As a Senior Statistical Programmer, you’ll have the opportunity to design and write program specifications for CDISC conversions, revise programs for corrections, independently create agency-accepted eSubmission deliverables, review statistical analysis plans and study documents, and provide feedback to Biostatistics. You’ll be able to consult with sponsors, internal and external project leads, and other programmers and lead the programming team on multiple studies.

This role can be fully remote in Poland.

Responsibilities

• 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 your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design.
• Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently author SDTM specifications from scratch; 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 and 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.
• Offer expertise relevant to statistical programming and CDASH data collection for study start up, execution, and close out: review protocols, draft CRFs; prepare and review validation plans, review vendor DTAs, etc.
• 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.

Qualifications

• BA/BS in computer science, statistics, or related field along with at least 5 years 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.
  • ADaM model and experience with both specification, programming, and conformance of ADaM CDISC is a plus.
  • SAS/Base knowledge with an emphasis on data step programming; competency modifying pre-existing SAS code, as well as writing SAS code from specs.
  • Clinical trials including 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: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
• Committed to Quality: Every job at Rho requires 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. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust.
• Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience.
• Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment.

A few more things to know about us:

Please submit your CV in English.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

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