About the job We offer: Developing at a rapidly growing, full-cycle pharmaceutical company. The company is focused on developing original molecules and is expanding globally into numerous international markets, including highly regulated ones. Join the team and play a key role in the registration process! Gain invaluable experience interacting directly with regulators across various countries with us! You will have to: Plan, distribute, and monitor the execution of tasks within the group based on planned activities over a period of up to a year, with weekly/monthly/quarterly detail. This work includes: - sample size calculation; - development of the statistical part of the research protocol; - programming randomization and kit lists; - review of the IRK specification; - planning statistical analysis; - consulting on the clinical development program; - review of reports and research results or other materials created by related departments based on the results of statistical analysis. Plan the group's work within the framework of registration processes in the markets of Russia and foreign countries. Interact with multiple cross-functional departments on clinical trial planning, statistical data analysis, and interpretation of statistical analysis results. Be a leader in improving and optimizing existing processes, as well as implementing new ones. Conduct development processes for the department's employees, with regular reporting and monitoring of interim results. Conduct trainings and educate colleagues. We expect you to: Have a higher education in mathematics or technology. Have worked in a relevant position in the field of clinical research for at least 7 years. We have been conducting projects in the field of biostatistics for more than 6 years. Understand the entire drug development process and how planning and data analysis processes fit into it. You have expert knowledge of statistical methods and regulatory requirements applicable to clinical trials, including those for the FDA and EMA markets. You have experience in creating new and maintaining existing business processes within the department that perform planning and statistical analysis of data. Created new and maintained existing quality management system documentation for the division (standard operating procedures, instructions, forms, manuals). Experience in building a team of biostatisticians, developing the team, and mentoring. Conducting interviews and guiding employees through probationary periods. Monitored employee business and personal goals. Worked on projects in oncology, autoimmune diseases, and orphan diseases. You have experience in the development of original and generic biotechnological drugs and chemical synthesis drugs. Your English level is not lower than Advanced. Conditions: The Passage boutique office is located in the heart of the city. Partial home office work is possible. Opening hours: 5/2, from 09.30 to 18.00 (on Fridays until 17.30). Competitive salary: base salary, annual bonus. Voluntary medical insurance policy with dental care after a probationary period. Wide opportunities for professional and career growth. B-WELL, an internal employee health and well-being support program, and programs to help employees in difficult life situations; and the PrimeZone corporate discount program (sports, recreation, restaurants, and training).