T2501 - Clinical Statistical Programmer (temporary 12 months contract)
Date de publication :
17 février 2025Type de contrat :
Durée indéterminée- Lieu de travail :Lausanne
Résumé de l'emploi
Debiopharm est une entreprise biopharmaceutique indépendante en Suisse. Rejoignez-nous pour améliorer la vie des patients!
Tâches
- Fournir un soutien en programmation statistique pour les études cliniques.
- Développer et valider des programmes statistiques pour les jeux de données.
- Collaborer avec les équipes pour assurer la conformité aux normes.
Compétences
- Master en informatique, statistiques ou biostatistiques requis.
- Compétence en programmation SAS pour l'analyse de données.
- Compréhension des normes CDISC et des exigences réglementaires.
Résumé de l'annonce originale
Est-ce utile ?
Debiopharm is an independent biopharmaceutical company based in Switzerland committed to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing, and digital health investment. Debiopharm International SA aims to develop innovative therapies addressing high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy, and then select large pharmaceutical commercialization partners to maximize patient access globally.
At Debiopharm, you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
Here: https://apply.workable.com/debiopharm-group-sa/
For our Biostatistics and Data Management department, based at our Headquarters in Lausanne, we are looking for a
Clinical Statistical Programmer (Temporary 12 Months Contract)
As a Clinical Statistical Programmer, you will provide statistical programming support for the analysis and reporting of assigned clinical studies, ensuring quality and adherence to timelines. You will work closely with biostatisticians and clinical study teams to generate analysis datasets and statistical reports, playing a crucial role in the clinical development process.
Your Main Responsibilities:
- Provide programming input to Case Report Form, clinical trial database design, and Statistical Analysis Plan (SAP).
- Develop, validate, and document statistical programs for generating analysis datasets, tables, figures, and listings (TFLs).
- Participate in the creation and review of specifications for analysis datasets and TFLs, ensuring compliance with standards.
- Perform ad-hoc programming as needed to support internal requests and regulatory inquiries.
- Collaborate with study teams to ensure adherence to Good Clinical Practice (GCP) and regulatory guidelines.
- Master’s degree in computer science, statistics, biostatistics, or related field.
- At least 3-5 years of experience in statistical programming in clinical trials within the pharmaceutical industry or CRO.
- Strong proficiency in SAS programming for data manipulation, statistical analysis, and reporting.
- Experience with CDISC standards and processes.
- Solid understanding of clinical trial data, statistical concepts, and regulatory requirements.
- Ability to work effectively in a team environment and communicate clearly with cross-functional teams.
- Excellent command of English (C1), knowledge of French is a plus.
- Demonstrated problem-solving skills and attention to detail.
Debiopharm can offer you
- Possibility to work from home with weekly visit in the office (Lausanne)
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.