P2269 - Senior Statistical Programmer, Clinical Development

Job content

Debiopharmis an independent biopharmaceutical company based in Switzerland with an ongoing commitment 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 that target 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 organization based at our Headquarters in Lausanne, we are looking for a

Senior Statistical Programmer

In this role, you will provide statistical programming support and lead programming related activities for the analysis and reporting of assigned clinical studies from Phase 1 up to Phase 3, and programs in Oncology and anti-infectives. You will be accountable for the quality and timelines of statistical programming deliverables, including for studies for which statistical programming activities are outsourced to CRO partners, working in close collaboration with Biostatisticians and the clinical study teams.

Your responsibilities will be but not limited to:

• Provide programming input to CRF, clinical trial database design and SAP
• Lead, contribute and provide oversight to the development of analysis datasets specifications, and tables, figures, and listings (TFLs) shells
• Perform, contribute and provide oversight for the development, validation, and documentation of statistical programs for the generation of analysis datasets, statistical tables, figures, and listing
• Perform ad hoc flexible and fast pace programming to support internal requests and answer regulatory questions
• Provide programming support for the preparation of Safety Update Reports and Investigators brochures
• Provide programming expertise and solutions to study teams
• Lead, contribute to the development of best practice to improve quality and efficiency
• Provide input and lead internal process improvement
• Ensure adherence to GCP, regulatory guidelines, standard processes, and SOPs

• Master’s degree in computer science, statistics or related field
• At least 7-8 years experience working the pharmaceutical industry, which at least 5 years’ experience as a SAS Programmer supporting clinical trials, from Phase 1 to Phase 3 in Pharmaceutical companies or CROs
• Significant SAS programming expertise gained within a clinical drug development setting
• Strong experience in using CDISC standards
• Good understanding of international regulatory, industry, and technology standards and requirements as per Clinical Development in the Pharmaceuticals Industry
• Used to work in a team environment with clinical team members, as part of Development teams
• Excellent command of English (C1), any other language is a plus
• You look for innovation, exploring latest technologies and standards to apply into Clinical Statistical Programming
• Proactive, you seek for an environment valuing your initiatives

• International, highly dynamic environment with a long term vision.
• Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
• Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
• Participation in a company where innovation, people and entrepreneurship are the fundamental keys to 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.