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Senior Director, Biometrics

Greater Copenhagen, Denmark
Our client is a global biotech company with an exclusive focus on the design and development of innovative medicines with an ambition of providing more safe and effective treatment to areas of high unmet medical needs. With two decades of experience, our client is a world leader in discovering and developing therapeutics in their field. Their advanced solutions and products aim to help thousands of people suffering from an array of chronic conditions and the product portfolio spans a range of already launched products and a strong pipeline of products in clinical development.

Our client utilizes a business model designed to optimize value through internal drug development and strategic partnerships, engaging in partnerships and collaborations that expand the opportunity and probability of success by providing additional resources and investments.
The Senior Director, Biometrics, will lead an integrated Biometrics function incorporating Biostatistics, Statistical Programming and Data Management, responsible for contributing to all phases of drug development. The role will set the direction for the team and ensure optimal task/resource management as well as personal/professional sparring and coaching with colleagues.

Additionally, the role will be responsible for developing functional infrastructure and building the Biometrics capabilities while exerting strategic, operational and technical leadership including but not limited to study design, conduct and analysis, regulatory interactions, publications, clinical development planning and excellence in CRO governance.
Position title:
Senior Director, Biometrics.
Reporting line:
Senior Vice President, Development
Reporting to the position: 10+ Biostatisticians, Statistical Programmers and Data Managers.
Location: Greater Copenhagen.
Traveling: Travel on a needed basis.
Responsibilities & Tasks:
  • Leading the biometrics organization by providing a clear purpose and direction.
  • Developing and managing biometrics strategy, processes, prioritizations and resource models/allocation that enable Client to deliver on its pipeline in an efficient and innovative manner.
  • Recruiting, developing, engaging and motivating the team.
  • Providing expertise and guidance in clinical study design while implementing efficient and effective practices in the execution and analysis of clinical trials.
  • Representing Client in meetings with regulatory agencies including providing justification and rationale for clinical trial design and statistical methods.
  • Driving Biometrics outsourcing processes to ensure strong vendor oversight, accountability and performance.
  • Managing relationships with collaborators and biometrics vendors, e.g., CRO’s.
  • Leading the development and application of new statistical methodology in support of research and development and keeping abreast of regulatory guidance and requirements in the global environment.
  • Ensuring successful study designs and development plans that incorporate forward-thinking statistical strategies.
  • Communicating effectively with internal team members, senior and executive management, key opinion leaders and regulatory authorities.
  • Enabling efficient data management and statistical programming methodologies.
  • Working closely with R&D cross-functional teams to execute effectively on R&D priorities and programs, ensuring timely and successful completion of projects.
Key success criteria:
  • Delivering excellence in the Biometrics execution on projects in support of Client’s overall R&D strategy.
  • Effectively ensuring appropriate progress in Biometrics activities and deliverables – hereunder meeting project timelines. 
  • Facilitating seamless collaboration between Biometrics team members and key internal stakeholders in e.g., Clinical Operations, Medical & Science, Safety, Medical Writing, RA, QA and others.
  • Ability to successfully alternate between the managerial aspects of the job and exercising operational skillset in e.g., statistics.
  • Ensuring effective management of CRO’s and other key vendors/partners.
  • Engaging on Development Management Team as a strategic contributor.
Educational background: Advanced degree in Biostatistics/Statistics and/or other relevant fields.
Language: Superior English skills (verbal and written).
Ideal experience:
  • 10+ years of biotech/pharmaceutical experience and with a comprehensive understanding of the R&D drug development lifecycle.
  • Demonstrated understanding of the clinical development process and interdependencies.
  • Comprehensive knowledge of statistical methodology with demonstrated ability of applying advanced methods in clinical trial design and analysis.
  • Proven track record of BLA/NDA/MAA experience including significant roles in regulatory interactions and advisory committee hearings.
  • Demonstrated experience in managing CRO’s effectively and holding them accountable.
  • Demonstrated ability to develop and nurture established teams - preferably with strong people management or matrix leadership experience
Personal & leadership competencies: Takes control/responsibility
Makes sure employees and stakeholders have a clear understanding of the direction, time horizons and project deliverables; drives projects forward with great agility to reach pivotal milestones; makes things happen and follows through.

Excellent communicator. Well-versed in verbal and written English and cross-cultural communication and presentation skills. Able to communicate complex scientific issues in a clear and straightforward way.

Works systematically; proactively organizes work and effort; is methodical in one's performance.

Inspiration and motivation
Inspires others, encourages the achievement of set goals by promoting a sense of purpose, provides inspiration for a positive work attitude and wish to succeed in the team.

Actively trying to improve the skills and talent of the employees by giving positive and constructive feedback. Provides training and tasks with a view to challenging their skills and encouraging development.

Team orientation
Works well with others with a view to obtain the team's objectives; shares information; supports others.


Assesses the importance of considerations, decisions and actions, analyses the most important issues first.

Makes rational, realistic and sound decisions based on the involvement of available facts and possibilities.

Intercultural understanding

Able to communicate with people from other cultures; operates effectively in a multi-cultural environment.


Solution oriented; Plans actions to secure optimal use of time and resources, compares achieved results to set objectives, follows up on delegated tasks and decisions.


Plans a focused course of action for himself/herself and others, ensures an appropriate assignment of tasks for employees, schedules an optimal use of resources.

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