Grupo Ferrer InternacionalAt Ferrer we use business to fight for social justice. We have long been a company that looks to do things differently;
instead of maximizing shareholder returns, we reinvest much of our profit in initiatives that give back to society. Back where it belongs. We go beyond compliance and are guided by the highest standards of sustainability, ethics and integrity. As such, since 2022, we are a B Corp.Founded in Barcelona in 1959, Ferrer offers transformative solutions for life-threatening diseases in more than one hundred countries. In line with our purpose, we have an increasing focus on pulmonary vascular and interstitial lung diseases and rare neurological disorders. Our 1,800-strong team is driven by a clear conviction:
our business is not an end in itself, but a way to change lives.We are Ferrer. Ferrer for good.Job descriptionThe 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 teamsWhy Ferrer?Make a positive impact in societyParticipate in volunteering activitiesGrow in a culture of trust, responsibility, and constructive feedbackEnjoy a flexible working model & collaborative office experience to enable innovation and teamworkingMake a real difference to the team and to yourselfTake advantage of opportunities for development & learningDiscover a range of benefits to support your physical, emotional and financial wellbeingCustomize your remuneration and benefitRequirementsWhat you’ll need to succeed You will rock at this company if you are a person with empathy, humility, curiosity and optimism.You will rock at this role if you match with:
PhD degree in Statistics, Biostatistics, or related field with relevant academic experience OR a master’s degree in Statistics or Biostatistics or a related field and 5 years of biostatistical experience in the clinical trials or health research environment required. Minimum of ten years of Clinical Development experience in the biopharmaceutical industry Experience in RWE and Late phase studies statistical participation is preferable SAS proficiency including BASE and STAT;
GRAPH preferred. Proficiency in Microsoft Word and Excel. If this great challenge matches your profile, then we are waiting for you!At Ferrer, we guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.Location:
Barcelona (Spain)Contract:
PermanentSector:
Pharmaceutical and biopharmaceuticalVacancies:
1Work modality:
Hybrid