Clinical Development Biostatistician
hace 2 meses
Ferrer is seeking a highly skilled Clinical Development Biostatistician to join our team. As a key member of our clinical development department, you will play a crucial role in ensuring the success of our clinical trials.
Key Responsibilities- Provide statistical input into clinical development plans and protocol development, including trial design, sample size estimation, randomization, and statistical methods for analysis.
- Coordinate closely with project management, clinical development, clinical operations, data management, pharmacovigilance, legal, finance, and regulatory teams to ensure operational excellence.
- Communicate with vendors regarding the development and conduct of study protocols or statistical analysis plans.
- Review and provide oversight for outsourced statistical activities, including analysis plans, consistency checks, data review, programming, and tables and figures specifications.
- Analyze clinical trial data, producing accurate results representing the outcome of the trial, and validate statistical output.
- Accurately interpret statistical results and concepts.
- Collaborate with the medical writer, clinical development lead, and clinical development medical lead to co-author final integrated reports of clinical trial data.
- Provide input into statistical standard operating procedures (SOPs) and general standardization efforts within the department.
- Participate in interactions with regulatory agencies, as required.
- Contribute to strategic planning to ensure optimized clinical development plans.
- Provide direction to setting goals that are aligned with both project and corporate goals.
- Collaborate effectively with members of clinical trial implementation teams.
- 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 and collaborative office experience to enable innovation and teamwork.
- Make a real difference to the team and to yourself.
- Take advantage of opportunities for development and learning.
- Discover a range of benefits to support your physical, emotional, and financial well-being.
- Customize your remuneration and benefits.
- PhD degree in Statistics, Biostatistics, or a 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 years of industry and other relevant biostatistical experience in the clinical trials or health research environment.
- Comprehensive understanding of ICH/GCP requirements, concepts, industry practice, and standards.
- International experience.
- 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.
- 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%).
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