Senior Statistical Programmer FSP

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Clinical Outcomes Solutions

Site WebLinkedInTous les Emplois

51 - 200 employés

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Clinical Outcomes Solutions est un cabinet de conseil mondial en résultats cliniques qui offre un soutien et des services complets dans tous les aspects de la recherche sur l'évaluation des résultats cliniques (COA). L'entreprise aide à informer les soins aux patients en capturant la voix des patients grâce à des méthodes scientifiques innovantes. Elle guide les organisations dans la navigation des complexités de la recherche sur les résultats cliniques en élaborant des stratégies et des solutions pour capturer des données précises. Fiable pour les entreprises pharmaceutiques et biotechnologiques, la société garantit la conformité réglementaire et l'optimisation des résultats pour les patients.

Description

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming • Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) • Production and QC / validation programming • Generating complex ad-hoc reports utilizing raw data • Applying strong understanding/experience of Efficacy analysis • Creating and reviewing submission documents and eCRTs • Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries • Performing lead duties when called upon • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. • Being adaptable and flexible when priorities change

🎯 Exigences

• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. • At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above. • Study lead experience, preferably juggling multiple projects simultaneously preferred. • Strong SAS data manipulation, analysis and reporting skills. • Solid experience implementing the latest CDISC SDTM / ADaM standards. • Strong QC / validation skills. • Good ad-hoc reporting skills. • Proficiency in Efficacy analysis. • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. • Submissions experience utilizing define.xml and other submission documents. • Experience supporting immunology, respiratory or oncology studies would be a plus. • Excellent analytical & troubleshooting skills. • Ability to provide quality output and deliverables, in adherence with challenging timelines. • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

🏖️ Avantages

• Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.