Job description:
1. FUNCTIONAL CONTENT
Main Role
Working in the field of Biometrics within the Global Scientific and Medical area. Lead and contribute to the development of clinical and medical programs by applying scientific methodology and data science (biostatistics/epidemiology).
The Clinical Biometrics Manager is responsible for the statistical approach applied to clinical program designs and for supporting the definition and execution of clinical trial strategies.
Contribute to clinical research, development, and medical affairs projects by leading the planning, design, programming, and oversight of data analyses, as well as the clinical and medical interpretation of both interventional and observational studies.
Act internally and externally as the company's representative in this area.
In ESTEVE's innovation model, the value of data generation, analysis, and interpretation is critical to differentiate our medicines. Relevant data may come from different sources (Clinical Trials, Observational Studies, Real World Evidence, Pharmacovigilance), generating diverse types of evidence that support the value of our medicines for patients' benefit.
Roles
* Provide expert opinion in biometrics/epidemiology aspects, integrating clinical/medical aspects (treatments, diagnosis, unmet needs, current trends) to apply the best data analysis methodology and design for robust evidence from clinical trials and observational studies sponsored by ESTEVE.
* Lead and contribute to the development and execution of strategies in the assigned Clinical Development and Medical Affairs Plans and study projects.
* Act as Study Biostatistician in Clinical and Medical Study Teams, responsible for methodological design and data analysis of assigned clinical development trials and observational medical studies.
* Provide statistical input into protocol development (trial design, sample size estimation, randomization, statistical methods for analysis) and other essential study documents (CRF development, edit checks for clinical trial data).
* Oversee these activities when delegated to third parties (Biometrics Expert role in Clinical Study Team). Communicate with vendors regarding study protocol or statistical analysis issues. Review and oversee outsourced statistical activities such as analysis plans, specifications for analysis files, consistency checks, data review, programming, and tables/figures specifications.
* Contribute to data and evidence generation in GSM Post-Authorization activities.
* Participate in Drug Safety Post-Authorization Studies and Signal Detection Analysis.
* Interpret results and participate in reports of assigned clinical development and medical studies.
* Generate and collaborate in writing scientific publications including CSR (Clinical Study Report) related to assigned projects and studies.
* Provide input into statistical SOPs and general standardization efforts within the department (methodology standards, standard data presentations).
* Promote and manage networking with opinion leaders and the scientific community in this area of expertise.
* Contribute to creating and developing the area of expertise on Biometrics and Biostatistics in ESTEVE.
2. ORGANIZATION CHART & JOB RELATIONSHIPS
* Line Manager: Global Clinical Development Head
3. JOB PROFILE
Required Studies:
* Degree in Medicine or Health Sciences and postgraduate studies in Statistics/Biostatistics/Epidemiology, or
* Degree in Statistics/Biostatistics/Epidemiology and postgraduate studies in Medicine or Health Sciences.
Other Specialized Knowledge:
* Proficiency in statistical analysis software (SAS, StatXact, R).
* Proficiency in Microsoft Office.
* Desirable: Training in Pharmacoepidemiology, Real World Evidence analysis, Pharmaceutical Investigation, Clinical Pharmacology.
* Desirable: PhD.
Languages:
* Spanish and English: mother tongue or proficiency level.
* Other languages will be appreciated.
Professional Experience:
* 8+ years of experience in clinical development/epidemiology, including relevant experience in design and execution of clinical trials/observational studies.
* Experience in Health Outcome study design.
* Demonstrated experience in participating in regulatory submissions at national and international level.
* Experience in medical writing for regulatory documents, publications, and study protocols/reports.