Associate Director Biostatistics, Early Phase

vor 1 Monat


Berlin, Deutschland Proclinical Vollzeit
Einleitung

Proclinical is seeking a dedicated and innovative individual for the role of Associate Director Biostatistics, Early Phase. This role is integral to our Biostatistics and Programming Department, where we are committed to providing innovative scientific and methodological solutions to accelerate clinical development. The successful candidate will be a key player in our Early Clinical Biostatistics team, contributing to the development strategy across all of the company's therapeutic areas (excluding oncology).

Responsibilities:

Provide leadership and guidance on one or more projects, being accountable for all methodological and statistical aspects. Act as a statistical consultant within the company. Drive international project teams to contribute to early development. Develop productive collaborations with other functions in the aligned study/project teams. Provide/develop statistical expertise within the team, department or cross-functions. Propose improvements to study designs, analyses and department efficiency. Stay informed with data being generated in the current clinical development programs and by competitors. Ensure high-quality contribution from study protocol to the clinical report. Participate in meetings with regulatory authorities and prepare submission dossier. Promote teamwork, innovation, quality, and operational efficiency. Provide technical guidance and mentoring to junior staff. Represent statistics in scientific or technical working groups or cross function initiatives.

Key Skills and Requirements:

PhD/MS in statistics or related discipline. Demonstrable experience in the pharmaceutical industry. Strong project/study management, interpersonal and communication skills. Strong capacity for anticipation, organisation and coordination. Leadership skills, including supervision of contractors. Ability to work as a team player and interact with all stakeholders. Broad knowledge and good understanding of advanced statistical concepts and techniques, including Bayesian techniques. Ability to propose and promote innovation in clinical development plans and analyses. Fluency in English.
Aufgaben


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