Executive Director, Biostatistics

🕒 il y a 17 jours

🌐 Royaume-Uni, Irlande – Distant

🇬🇧 Royaume-Uni – Télétravail 🇮🇪 Irlande – Télétravail

⏰ Temps Plein

🔴 Expert

👔 Directeur

🇬🇧 Parrain de Visa de Travailleur Qualifié UK

Cette entreprise a parrainé des visas de Travailleur Qualifié du Royaume-Uni par le passé.

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Parexel

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1983

💼 Conseil

🏥 Santé

📦 Logistique

💰 Venture Round en 1990-01

Consulting • Healthcare • Logistics

Parexel est l'une des plus grandes organisations de recherche clinique (CRO) au monde, fournissant des services complets pour le processus de développement clinique de la Phase I à IV. L'entreprise se spécialise dans la gestion de portefeuille, la gestion des essais cliniques, la stratégie réglementaire, l'accès au marché et la gestion du cycle de vie des produits biopharmaceutiques. Parexel vise à accélérer la mise sur le marché de médicaments qui changent la vie en tirant parti de son expertise clinique, réglementaire et thérapeutique. Avec une équipe mondiale de plus de 21 000 professionnels, Parexel s'efforce d'intégrer les perspectives des patients et des conceptions d'essais innovantes pour développer des traitements dans des domaines thérapeutiques tels que l'oncologie, les neurosciences, les maladies rares et plus encore. Elle se concentre sur la fourniture d'essais cliniques centrés sur le patient et efficaces.

Description

• Provide statistical consulting and guidance throughout the clinical development process • Provide statistical expertise in the design of clinical development programs and individual protocols • Optimize existing protocols and prepare submissions across therapeutic areas and indications • Interact with clients and regulatory authorities, including representing clients at key regulatory meetings • Lead or contribute to client meetings on innovative study designs, analysis concepts, and presentation, discussion, and interpretation of study results • Provide technical leadership and advise internal teams on advanced or innovative statistical designs, models, applications, and complex statistical issues in clinical trials • Attract new business by serving as a Biostatistics expert and partnering with Business Development, Medical, Solutions Consultants, and other functions • Contribute to proposal development and attend bid defense meetings • Represent Parexel at client marketing and technical meetings and support lead generation through networking, public speaking, and thought leadership • Coordinate client or account activities for the department or function • Participate in committees and task force groups • Partner with senior departmental management to develop biostatisticians • Maintain working knowledge of and ensure compliance with ICH Guidelines, Good Clinical Practices, regulatory agency requirements, and Parexel standard operating procedures • Participate in departmental meetings, training initiatives, and project team meetings • Maintain effective relationships with departments, clients, and regulatory agencies

🎯 Exigences

• PhD in Statistics or a related discipline, or MS in Statistics or a related discipline • Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge • Direct consulting experience • Experience designing and executing drug, device, or diagnostic development programs • Demonstrated successful direct interactions with relevant regulatory agencies such as FDA, EMEA, MHRA, PMDA, NMPA, or other local agencies • Experience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participation • Thorough understanding of regulatory guidance and practices related to specific indications and the submission and approval process • Experience with conference presentations and manuscript writing • Excellent organizational, communication, negotiation, problem-solving, analytical, and consulting skills • Technical leadership and ability to contribute to a high-performing team • Expertise in innovative trial designs, protocol and development program optimization, submission strategies, and regulatory interactions • Strong understanding of drug, device, or diagnostic development across different therapeutic areas and indications • Thorough understanding of statistical models, applications, and statistical issues in clinical trials • Ability to collaborate across functions and communicate complex statistical concepts credibly to clients, internal teams, and regulatory authorities • Preferred: expertise across multiple therapeutic areas and indications • Preferred: experience advising on advanced or innovative statistical designs, models, and applications • Preferred: experience supporting proposals, bid defense meetings, client presentations, public speaking, or thought leadership

🏖️ Avantages

• Occasional travel, mostly within Europe • Applicable bonus plans or incentive structures for eligible positions

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