CLINICAL DEVELOPMENT BIOSTATISTICIAN LEAD

The Clinical Development Statistician Lead has responsibility for Statistical approach applied to the Clinical Programs designs and its Clinical trial strategy definition and execution support. Designs, Coordinates and supervise the Statistical aspects for clinical research activities, including but not limited to clinical development of ongoing programs and new assets assessment/development. Close and strategic cooperation with other R&D departments, regulatory affairs, and medical affairs to ensure alignment and effective planning throughout the clinical development process. All activities will be conducted in compliance with Ferrer QMS, ICH/GCP, and all applicable regulations and guidelines, ensuring compliance with company targets and maximum quality standards. Reports to the Clinical Development Director. 

Responsibilities

• Provides statistical input into protocol development (e.g., trial design, sample size estimation, randomization, statistical methods for analysis) and other study essential documents (case report (CRF) development, edit checks for clinical trial data…) 
• Communicates with vendors regarding study protocol or statistical analysis issues. 
• Reviews and oversight outsourced statistical activities such as analysis plans including specifications for analysis files, consistency checks, data review, programing, and tables and figures specifications. 
• Analyzes clinical trial data producing accurate results representing the outcome of the trial. Validates statistical output.
• Accurately interprets statistical results and concepts.
• With the medical writer, Clinical development Lead and Clinical development medical lead co-authors final integrated reports of clinical trial data by securing thorough and clear statistical methods sections and the statistical appendix for the final report. 
• Provides input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.g., statistical methodology standards, standard data presentations). 
• Participates in interactions with regulatory agencies, as required. 
• Collaborates effectively with members of clinical trial implementation teams

Why Ferrer?

• Make a positive impact in society
• Participate in volunteering activities
• Grow in a culture of trust, responsibility, and constructive feedback
• Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
• Make a real difference to the team and to yourself
• Take advantage of opportunities for development & learning
• Discover a range of benefits to support your physical, emotional and financial wellbeing
• Customize your remuneration and benefit