CLINICAL DEVELOPMENT BIOSTATISTICIAN LEAD

Ferrer

  • Barcelona
  • Permanente
  • Tiempo completo
  • Hace 1 mes
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 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
RequirementsWhat you'll need to succeedYou 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.

Ferrer