Proclinical

Proclinical has partnered with biopharmaceutical company in search for a talented and dynamic Principle Biostatistician, to join their transnational science team. This is an opportunity to design, plan, and execute biostatistical components of clinical trials. Uses sound statistical methodology to conduct studies, prepares the statistical components of protocols, and is responsible for the statistical components of reports. Job Responsibilities Applies knowledge of statistical methodology to ensure proper implementation of clinical trials. Provides statistical oversight across the whole clinical trial. Develops statistical analysis plans and reporting specifications for clinical trials. Reviews reports and underpins the results with statistical expertise. Accountable for the quality and delivery of the table, figure, and listing (TFL) packages. Analyzes and interprets results from clinical trials using sound statistical met Skills and Requirements Minimum...

Proclinical is in search of a Clinical Development Medical Director with a speciality in oncology, in Switzerland. This role is responsible for implementing clinical drugs for oncology products from Phase I through to Phase III. If you're interested in driving healthcare forward this might be the role for you. Job Responsibilities Provides medical and scientific expertise for internal cross-functional team members for development of specific anti-neoplastic agents including discovery scientists, medical scientists, biostatisticians, pharmacokineticists, pharmacovigilence and clinical operations Interacts with global regulatory bodies including the FDA and EMA to accomplish tasks related to oncology product development and collaborates with internal regulatory experts and oversee the clinical research plans and sections for Investigational new Drug applications (INDs) and New Drug Applications (NDAs) Facilitates the development of key internal and external documents...

A global swiss pharmaceutical organisation is looking for a Manager in Statistical Programming to provide functional expertise and leadership to clinical projects and studies. The selected candidate will be responsible for establishing programming standards. Job R esponsibilities: Ensure quality of Statistical Programming deliverables by consistently applying analysis and reporting standards and driving compliance with SOPs and regulatory requirements. Manage a team of statistical programmers and the resource planning for their assigned studies. Oversee the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries. Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions. Provide technical guidance to vendors around project standards, programming conventions/specifications and programming practices to ensure...