Rishat Gabidullin Email & Phone Number

Saint Petersburg, Ru

St Petersburg City, Russia

The biostatistics unit performs a full range of tasks related to planning statistical analysis as part of the clinical development of all company's drugs in all markets where the company is present (more than 30 countries). Main directions are oncology, autoimmune diseases and orphan diseases. All phases of studies are conducted. Biosimilar, generic and original drugs.• Defining the tasks of the biostatistics unit based on the company's clinical development plans: (during the first 8 months of work in the position, I increased a detailed planning horizon of the team’s tasks several times).• Prioritization and management of deadlines for tasks (8 direct reports).• Optimization and creation of new business processes for the unit (as well as the joint development of cross-functional business processes) in order to improve the quality of results. Organization of the development and updating of documentation for the quality management system.• Determining the level of qualifications of specialists and the number required to meet the current and future needs of the department.• Hiring specialists for the team (determining the requirements for candidates and conducting interviews), as well as assessing the suitability of employees to the current and future needs of the company. During my tenure, the number of specialists in direct management has more than doubled. The team consists of specialists ranging from entry-level to expert.• Ensuring the professional growth of the biostatistics team, the implementation of new methodologies that align with current scientific knowledge and meet regulatory requirements for the company's target markets.• Organization of cross-functional collaboration between the biostatistics team and other departments within the company, task planning with relevant departments to ensure continuity of R&D processes within the company.• Quality control of documents generated by the biostatistics team for selected projects.

St Petersburg City, Russia

- Statistical input in study protocols, sample size calculation.- SAP and shells preparation, and QC of these documents: (I introduced the practice of preparing statistical analysis plans for clinical research and ISS/ISE within the division. I also developed the necessary SOPs and document templates.)- Statistical modeling of clinical research processes.- QC (double programming) of deliverables (tables, listings, figures) with SAS and R.- Clinical study report review, statistical part of a report preparation.- Trainings for colleagues on biostatistics: (I have prepared and delivered lectures on biostatistics for the SAS School of BIOCAD, which is an educational initiative of the company aimed at training SAS programmers from the ground up. I have covered half of the entire biostatistics course as part of this project.)

Trainings on data analysis, consultation on specific issues related to biostatistics projects, and advice on the development of the company's biostatistics department.

Russia

- Responsible for day-to-day management of the compan (about 30 specialists by 2020): (I ensured the company's successful resolution of the challenging situation that arose following the change in ownership and loss of key personnel. The company managed to maintain its position in the clinical research market and continue its development trajectory.)- Strategic planning, including financial planning, and implementation of plans.- Organization of business processes in the company: (Under my leadership, we have updated and implemented new business processes, and created an IT infrastructure that supports the company's operations to date. All specialists work remotely.)- Development of the quality management system and employees training system in the company: (The result was the successful completion of the vendor assessment by international CROs and pharmaceutical companies, which led to subsequent orders from these companies.)- Participation in the selection process for specialists and conducting interviews with candidates for project department positions (specialists at different levels, project managers).

Russia

- Project management in data management and biostatistics (up to 5 professionals, about 10 project for this period): (I have organized the department into an independent unit with appropriate business processes in place, and have ensured its coordination with the medical writing team.)- Quality assurance in data management and biostatistics projects: (Most of the projects are recurring, indicating that the company has established a regular customer base.)- Interaction with clients (pharmaceutical companies and contract research organizations) at all stages of projects, from the commercial proposal through to the signing of a completed work act.- Conducting the process of selecting and interviewing candidates for positions in the fields of biostatistics and data management.- Participation in some projects as a biostatistician or a data manager.

Россия

- Development of paper and electronic case report forms (CRFs), leadership of a team of data entry operators while working with paper CRFs, and data cleaning: (For the first time at the company, I implemented OpenClinica (an electronic data capture system), worked out technical issues, and created training materials for employees.)

Russia

• Remote project teams management;• Negotiations with customers (pharmaceutical companies, CROs).

Russia

- Development of the main documents of the clinical trial, literature reviews.- Planning and conducting statistical analysis using Stata and R.

Ufa, Russian Federation

- Teaching pharmacology to medical students- Experimental pharmacology research and statistical analysis of research results.

Principles And Practice Of Clinical Research

Phd, Pharmacology

Specialist Degree, General Mdecine