Global Head Biostatistics

Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. We also take pride in having a great working climate!

Our vision is to bring unique life-improving therapies to patients with rare diseases. Egetis Therapeutics currently has two drug candidates in late-stage clinical development, and we are continuously seeking opportunities to grow our pipeline. We are now on an exciting journey to establish our own teams for product launches in Europe and North America.

We are committed, courageous, and collaborative people. Become a part of our inspiring environment. We care for the rare!

Duties and Responsibilities

As Global Head Biostatistics, you are responsible for the strategic and operational statistical leadership

• Accountable for developing statistical strategies for drug projects in development and commercial phase.
• Accountable for planning and leading activities, employees, and consultants in the areas of data management, programming, and statistics.
• Accountable for delivery of the statistical contributions to regulatory marketing applications and interactions with Health Authorities including scientific advisory meetings and responses to requests from regulatory agencies
• Accountable for providing statistical guidance to support business development, including due diligence for potential in-licensing, external collaborations, and acquisitions
• Accountable for delivery of statistical activities in clinical development, including e.g

• • statistical design of clinical studies and sample size calculations
• • statistical analysis plans
• • programming of study databases, e.g. SDTM and ADaM
• • quantitative monitoring of ongoing clinical studies
• • statistical analysis and interpretation of study results
• • statistical modelling
• • randomization and electronic data capture system set-up and eCRF design

You will report to our VP Product Strategy and Development.

We have an Office downtown Stockholm where you are welcome to join us for work. However, we are flexible if you prefer to work from home anywhere in the world.

Your Background

Extensive experience in Biostatistics during drug development including leading positions (minimum 15 years)

Scientific background: MSc, PhD or equivalent

Global leader role experience in internal, as well as external, collaborations.

Competencies

Manage Complexity: Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.

Make sound decisions: Make good and timely decisions that keep the organization moving forward.

Action Oriented: Taking on new opportunities and tough challenges with a sense of urgency, high energy and enthusiasm.

Direct Work: Providing direction, delegating and removing obstacles to get work done.

Plan and align: Planning and prioritizing work to meet commitments aligned with organizational goals.

Ensure Accountability: Holding self and others accountable to meet commitments.

Manage Ambiguity: Operating effectively, even when things are not certain or the way forward is not clear.

Values

Naturally you share our values:

Courage - We challenge the status quo for the benefit of the patient

Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results

Collaboration – Through trust, we work seamlessly across functions and with external partners