Senior Director, Biostatistician and Head of Biometrics
6 days ago
We are seeking a highly experienced Senior Director, Biostatistician and Head of Biometrics to lead our Biometrics function at Planet Pharma. This is a critical role that will be responsible for establishing and leading the Biometrics function, ensuring integration across all clinical programs.
Key Responsibilities- Leadership and Strategy: Develop and execute the global biometrics strategy in alignment with the company's clinical development and regulatory goals.
- Operational Management: Build and lead a high-performing biometrics team, fostering a culture of excellence, collaboration, and innovation.
- Regulatory Compliance: Ensure all biometrics activities comply with global regulatory requirements, including FDA, EMA, and other international health authorities.
- Cross-Functional Collaboration: Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and other cross-functional teams to ensure seamless integration of biometrics into the clinical development process.
- Innovation and Continuous Improvement: Stay abreast of emerging trends and innovations in biostatistics, data management, artificial intelligence (AI) and statistical programming, incorporating best practices into the biometrics function.
- Advanced degree in biostatistics, statistics, mathematics, or a related field (PhD strongly preferred).
- A minimum of 10 years of experience in biostatistics and biometrics within the biopharmaceutical industry.
- Extensive experience with global regulatory requirements and submissions, including FDA and EMA guidelines.
- Proven track record of building and leading successful biometrics teams and functions.
- Experience in using artificial intelligence, large language models, handling of big data.
- Experience in start-up / scale up companies.
- Experience building out functions / departments.
- Experience in people management and leadership.
- Ethics: Treats people with respect; Shows respect and sensitivity for cultural differences; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values; Promotes a harassment-free environment.
- Teamwork: Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
- Adaptability: Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
- Analytical: Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
- Effective Communication: Writes clearly and informatively, with attention to spelling and grammar; adapts writing style to meet various needs; presents numerical data effectively; able to read and interpret written information; speaks clearly and persuasively in different situations; listens actively and responds well to questions; demonstrates strong presentation skills and participates effectively in meetings.
- Innovation: Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
- Interpersonal Skills: Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
- Strategic Thinking: Develops strategies to achieve organizational goals; Understands organization's strengths and weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
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