Job title:
Clinical Development Biostatistician
Company:
Ferrer
Job description
Job descriptionWho we areAt Ferrer we are a group of people who believe in the power of purpose. And our purpose is to make a positive impact in society and bring about change in an unjust world. We are the 24/7 activists fighting for a sustainable planet, equal opportunities for all and a healthy workplace. We reject greenwashing and empty promises – we are about action. That is why in 2022 we became a B Corp company.Founded in Barcelona in 1959, our products are present in more than a hundred countries, and we have a team of over 1,800 people. Professionals that we empower to became leaders of change and to build meaningful careers.Responsibilities
- Provides statistical input into clinical development plans and 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…)
- Coordinate closely (Internally or outsourced) with Project management, Clinical Development, Clinical Operations, Data Management, Pharmacovigilance, Legal, Finance, Regulatory to ensure operational excellence.
- Communicates with vendors regarding the development and conduct of study protocols or statistical analysis plans.
- Reviews and provides oversight for 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.
- Contributes to strategic planning to ensure optimized Clinical Development Plans
- Provides direction to setting goals that are aligned with both project and corporate goals.
- 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
Requirements
- 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 a minimum of 10 years of Industry experience, or a minimum of 10 of Industry and other relevant biostatistical experience in the clinical trials or health research environment required.
- Must have a comprehensive understanding of ICH/GCP requirements, concepts, industry practice and standards.
- Must have international experience.
- Must have a working knowledge of data management and pharmacovigilance.
- Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials required.
- 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.
- Strong level of detail orientation.
- Ability to work on multiple tasks and projects under tight timelines.
- Travel required (5-10%)
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.
Expected salary
Location
Barcelona
Job date
Sat, 20 Jul 2024 01:08:44 GMT
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