Safety Expert Statistician (M/W/D) - Festanstellung

OC Recruitment – Ihr Personalberater in den Life Sciences. Ihr Partner in Sachen Personalberatung in den Bereichen Pharma, Biotechnologie sowie Medizintechnik.

Wir vermitteln Fachkräfte auf Zeit und in Festanstellung/Direktvermittlung, d.h. die Einstellung erfolgt direkt beim Kunden. KEINE Zeitarbeit. In Deutschland. In Österreich. In der Schweiz.

Aufgaben

Für unseren Kunden aus Frankfurt suchen wir einen Safety Expert Statistician (m/w/d) mit den nachfolgenden Aufgaben:

• Lead safety signal detection, validation, charaterisation and reporting for several projects with minimal direction from group head, direct statistical support and provide statistical scientific leadership for clinical trial safety data within a project. Accountable for statistical aspects for safety analysis, including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.
• Accountable for all safety statistical deliverables for complex projects
• Plan and track project activities related to safety, timelines, and resource use and promoting teamwork
• Lead discussion around definition and harmonization of quality standards also on individual trial level within and across therapeutic areas
• Provide technical guidance and mentoring to junior staff
• Ensure productive collaborations with other functions in the safety monitoring team and with other statistics project leaders and in communicating with senior leadership
• Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross function initiatives. Contribute to operation process optimization

Qualifikation

Education and professional Experience

• PhD/MS in statistics or related discipline
• Broad experience in clinical development or post-marketing activities such a submissions, interactions with regulatory agencies or other external stakeholders and experience safety signal detection desired

Soft skills

• Demonstrated strong project/study management, interpersonal and communication skill
• Broad knowledge and good understanding of advanced statistical concepts and techniques, including bayesian methodology
• Ability to represent the company in cross-company activities such a consortiums or professional associations
• Ability and mindset to embrace change, innovate and continuously improve practice

Languages

• Fluency in German and English (both written and spoken).

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