Manager, Global Biostatistics and Programming

🕒 il y a 1 mois

🌲 North Carolina – Distant

🌲 North Carolina – Remote

💵 $132 900 - $199 400 / an

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

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Teleflex

Site WebLinkedInTous les Emplois

10 000+ employés

⚕️ Assurance santé

💊 Pharmaceutique

💰 €275 000 Venture Round en 2010-01

Healthcare Insurance • Medical Devices • Pharmaceuticals

Teleflex est un fournisseur mondial de dispositifs médicaux innovants et de solutions, dédié à soutenir les professionnels de santé et à améliorer les soins aux patients. Avec un portefeuille diversifié incluant des produits pour l'anesthésie, la médecine d'urgence, la cardiologie interventionnelle et bien plus, Teleflex vise à améliorer la santé et la qualité de vie. L'entreprise met l'accent sur son engagement envers l'éducation et le support client dans le secteur de la santé.

Description

• Developing and implementing statistical analysis plans (SAPs) as well as producing the key clinical data outputs that align with the evidence generation needs across the organization • Provide strategic input during controlled clinical trial and real-world study protocol development and publication planning and execution • Manage work and consultants who are directly responsible for biostatistics input, support, and guidance; as well as strategic analysis and programming activities • Perform interim analyses and monitor the quality of data management deliverables during clinical trial execution • Cultivate a plan for sustaining biostatistics and programming for the Interventional Urology business unit • Manage external contractors/consultants, ensuring timelines are met according to objectives and goals and/or data reporting needs • Represent Teleflex in a customer-facing position with high levels of professionalism, service, and ethics • Demonstrate initiative and critical thinking to identify, prioritize process and performance gaps • Build collaborations with Clinical and Medical Affairs teams to align biostatistical analysis with global evidence generation plans

🎯 Exigences

• Master’s degree in a quantitative discipline (e.g., statistics, operations research, bioinformatics, economics, computational biology, computer science, mathematics, physics, electrical engineering, industrial engineering) with at least 10 years of direct biostatistics and programming experience in a pharmaceutical, medical device, clinical, or academic research setting required • Minimum of 3 years working on projects, including Urology therapies • Minimum of one year of prior experience managing/leading other team members or consultants • SAS Expertise required; certification preferred • Strong knowledge of US and international clinical regulations and guidance • Strong computer skills in Microsoft Office; high proficiency using electronic data capture systems and off-the-shelf data software • Ability to prioritize analytical deliverables through stakeholder management and negotiate timelines as needed • Ability to make independent decisions and take ownership within a fast-moving environment • Excellent organizational skills and attention to detail • Excellent verbal and written communication skills, including presentation skills • Ability to collaborate effectively and participate in a team environment • Ability to travel up to 5-10% of the time. Overnight and international travel may be required.

🏖️ Avantages

• medical, prescription drug, dental and vision insurance • flexible spending accounts • participation in a 401(k) savings plan • various paid time off benefits, such as PTO, short- and long-term disability, and parental leave