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Clinical Development Biostatistician
hace 2 meses
We are seeking a highly skilled Clinical Development Biostatistician to join our team at Ferrer. As a key member of our Clinical Development department, you will play a crucial role in the design, development, and implementation of clinical trials.
Key Responsibilities- Statistical Input and Protocol Development: Provide statistical input into clinical development plans and protocol development, including trial design, sample size estimation, randomization, and statistical methods for analysis.
- Collaboration and Communication: Coordinate closely with Project Management, Clinical Development, Clinical Operations, Data Management, Pharmacovigilance, Legal, Finance, and Regulatory teams to ensure operational excellence.
- Vendor Management: Communicate with vendors regarding the development and conduct of study protocols or statistical analysis plans.
- Statistical Oversight: Review and provide oversight for outsourced statistical activities, including analysis plans, data review, programming, and tables and figures specifications.
- Data Analysis and Interpretation: Analyze clinical trial data, producing accurate results representing the outcome of the trial, and validate statistical output.
- Statistical Reporting: Accurately interpret statistical results and concepts, and co-author final integrated reports of clinical trial data.
- Statistical Standardization: Provide input into statistical standard operating procedures (SOPs) and general standardization efforts within the department.
- Regulatory Interactions: Participate in interactions with regulatory agencies, as required.
- Strategic Planning: Contribute to strategic planning to ensure optimized Clinical Development Plans.
- Goal Setting: Provide direction to setting goals that are aligned with both project and corporate goals.
- Team Collaboration: Collaborate effectively with members of clinical trial implementation teams.
Ferrer is a company that values making a positive impact in society. We believe in the power of purpose and strive to bring about change in an unjust world. As a Clinical Development Biostatistician, you will be part of a team that is passionate about creating a sustainable planet, equal opportunities for all, and a healthy workplace.
We offer a range of benefits to support your physical, emotional, and financial wellbeing, including a flexible working model, collaborative office experience, and opportunities for development and learning.
Requirements- Education and Experience: 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.
- ICH/GCP Requirements: Must have a comprehensive understanding of ICH/GCP requirements, concepts, industry practice, and standards.
- International Experience: Must have international experience.
- Data Management and Pharmacovigilance: Must have a working knowledge of data management and pharmacovigilance.
- Communication Skills: 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.
- Technical Skills: SAS proficiency, including BASE and STAT; GRAPH preferred, and proficiency in Microsoft Word and Excel.
- Attention to Detail: Strong level of detail orientation.
- Time Management: Ability to work on multiple tasks and projects under tight timelines.
- Travel: Travel required (5-10%).
