Executive Director, Biostatistics

Job not on LinkedIn

🔥 1 minute ago

🌐 United Kingdom, Ireland – Remote

🇬🇧 United Kingdom – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🔴 Lead

👔 Director

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

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