Senior Director, Biostatistician and Head of Biometrics

3 weeks ago

New York, United States Planet Pharma Full time

Job Description:
The Senior Director, Biostatistician and Head of Biometrics will be responsible for establishing and leading the Biometrics function within the company. Reporting directly to the Chief Development Officer, this role will be critical in developing the strategy, systems, and processes necessary to support clinical development programs, regulatory submissions, and overall data-driven decision-making. The ideal candidate will have deep expertise in biostatistics, data management, and statistical programming, coupled with strong leadership skills and experience building high-performing teams.Essential Duties and ResponsibilitiesLeadership and Strategy:

Develop and execute the global biometrics strategy in alignment with the company’s clinical development and regulatory goals.
Establish and lead the biometrics function, including biostatistics, data management, and statistical programming, ensuring integration across all clinical programs.
Provide strategic input into the design and execution of clinical trials, ensuring robust statistical methodologies are applied.


Operational Management:

Build and lead a high-performing biometrics team, fostering a culture of excellence, collaboration, and innovation.
Oversee the development, implementation, and maintenance of biometrics processes and systems, ensuring data integrity and compliance with regulatory standards.
Lead the planning and execution of statistical analyses, ensuring accurate and timely delivery of high-quality data for clinical trials and regulatory submissions.


Regulatory Compliance:

Ensure all biometrics activities comply with global regulatory requirements, including FDA, EMA, and other international health authorities.
Lead the statistical aspects of regulatory submissions, including the preparation of statistical analysis plans (SAPs), clinical study reports (CSRs), and responses to regulatory inquiries.
Serve as the primary biometrics representative in interactions with regulatory agencies and key opinion leaders.


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.
Provide expert statistical consultation and guidance to internal stakeholders, supporting data-driven decision-making across the organization.


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.
Lead the development and implementation of new statistical methodologies and technologies to enhance the efficiency and effectiveness of clinical trial design and analysis.


Risk Management:

Identify and manage risks related to statistical design and data quality, implementing strategies to mitigate potential issues.
Ensure that all biometrics activities are conducted with the highest level of scientific rigor and ethical standards.


Performs other related duties as assigned by management.


Required Qualifications:

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.


Strong strategic and analytical thinking, with the ability to develop and execute comprehensive biometrics strategies.
Expertise in statistical methodologies and clinical trial design, with a deep understanding of the biopharmaceutical industry.
Excellent leadership and team-building skills, with the ability to inspire and motivate a diverse team.
Superior communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders, including regulatory authorities.
Proficiency in statistical software (e.g., SAS, R) and data management tools.


Preferred Qualifications

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


Competencies

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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