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Statistical Programmer II

Il y a 2 mois

Paris, Île-de-France Cytel Temps plein
Job Summary

Cytel is seeking a highly skilled Senior Statistical Programmer to join our team in a key role that will drive the success of our clinical trials. As a seasoned professional in biostatistics and statistical programming, you will be responsible for providing technical expertise and leadership to support the development of clinical trials.

Key Responsibilities
  • Technical Expertise: Provide significant technical expertise for statistical programming in all phases of programming support, developing automated reports, and preparation of submission data standard packages.
  • Project Leadership: Support statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects, and lead one or more clinical trials across various therapeutic areas.
  • Statistical Analysis: Develop and execute statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures.
  • Dataset Design: Design and maintain statistical datasets that support multiple stakeholder groups.
  • Collaboration: Serve as a key collaborator with statistics and other project stakeholders to ensure that project plans are executed efficiently with timely and high-quality deliverables.
  • Knowledge Holder: Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocol.
  • Programming Development: Develop and validate programming code using global and therapeutic area standards, following departmental SOPs and good programming practices.
  • Project Management: Maintain and manage a project plan, including resource forecasting.
  • Team Coordination: Coordinate the activities of the supplier's programming team and interact with client statistical programmers.
  • Leadership: Utilize strong project management skills and ability to engage key stakeholders, lead at a protocol level, determine approach, and ensure consistency.
  • Algorithm Design: Design and develop complex programming algorithms.
  • Analysis Plan: Comprehend analysis plans that may describe methodology to be programmed, and understand statistical terminology and concepts.
  • CDISC and ADaM Standards: Utilize expertise in CDISC and ADaM standards.
  • Statistical Programming: Provide statistical programming for early and late-stage clinical trials, including both planned and ad-hoc needs.
  • Datasets: Enriched/Post-Processed Datasets (individual or integrated), ADaM datasets (individual or integrated), protocol and therapeutic area-specific tables, listings, and figures (individual or integrated).
  • Programming Documentation: Develop programming documentation following SOPs.
Requirements
  • Education: Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
  • Experience: 6 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines.
  • Leadership Experience: Study lead experience working with cross-functional teams, including leading programming teams.
  • QC and Validation: Strong experience in QCing and validating work of other programmers, preferably outsourced work.
  • SAS Skills: Strong SAS data manipulation, analysis, and reporting skills, with strong output programming experience.
  • CDISC Standards: Strong proficiency implementing the latest CDISC SDTM/ADaM standards.
  • Drug Development Life Cycle: Familiarity with the drug development life cycle and experience with the manipulation, analysis, and reporting of clinical trials' data.
  • Submissions Experience: Submissions experience utilizing define.xml and other submission documents.
  • Analytical and Troubleshooting Skills: Excellent analytical and troubleshooting skills.
  • Quality and Timeliness: Ability to provide quality output and deliverables, in adherence with challenging timelines.
  • Global Teamwork: Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Why Cytel?
  • Collaborative Environment: Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
  • Competitive Benefits: In addition to a competitive compensation, we offer an excellent benefits package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us
  • Expertise and Thought Leadership: Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.