Associate Director, Biostatistics

🔥 23 hours ago

🌐 Germany, Belgium, +6 more countries – Remote

🇩🇪 Germany – Remote 🇧🇪 Belgium – Remote 🇳🇱 Netherlands – Remote 🇬🇧 United Kingdom – Remote 🇮🇪 Ireland – Remote 🇪🇸 Spain – Remote 🇧🇬 Bulgaria – Remote 🇮🇹 Italy – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Collaborate with internal program staff and sponsors on statistical aspects of research protocols • Provide statistical consultation on protocol development, randomization, sample size assessments, efficacy evaluations, and data review • Define and manage project timelines and ensure deadlines are met • Ensure high-quality completion of project tasks for internal and external clients • Review, approve, and develop statistical analysis summaries and analysis plans, including planned analyses and data-display mock-ups • Oversee and/or perform statistical analyses, including hypothesis testing and modeling • Interact with Medical Writers and contribute relevant sections of clinical study reports • Interface with clients and regulatory agencies as project biostatistician • Oversee a program of studies • Assist in defining and maintaining departmental standards, SOPs, and working practices • Provide leadership, mentoring, and statistical support to Biostatistics staff • Assist with training-material development and training delivery for Clinical Reporting staff • Present Clinical Reporting processes and procedures to clients and other interested individuals • Assist with project-task and resource coordination across Biostatistics and act as backup during the Manager's absence • Perform other assigned duties

🎯 Requirements

• Masters-level degree in Statistics, Biostatistics or related field with eight years relevant CRO industry or biotech experience; or Doctorate-level degree in Statistics, Biostatistics or related field with six years relevant CRO industry or biotech experience • Data handling and analysis experience • Extensive oncology drug development experience across a broad range of oncology indications • Demonstrated expertise applying advanced statistical methodologies throughout the clinical development lifecycle • Senior-level statistical review and oversight of SAPs, ADaM specifications and datasets, TLFs, and other study deliverables • Experience with regulatory submissions and interacting with regulatory agencies • Experience participating in and leading bid defense meetings • Ability to mentor, develop, and support biostatistical staff across global regions • Strong customer engagement and relationship management skills • Understanding of GCP, ICH, and FDA guidelines and regulations applicable to clinical research • Advanced knowledge of statistical methods used in Phase I-IV clinical trials • Experience with SAS Base and SAS Stat • Experience with statistical software packages such as N-Query and S-Plus • Ability to work creatively and independently on complex assignments • Effective time management skills • Ability to work effectively and cooperatively with professional staff • Effective verbal and written communication skills • This role is not eligible for UK visa sponsorship

🏖️ Benefits

• Work from home • Leadership development opportunities • International team environment • Mentoring and professional development opportunities • Training materials and Biostatistics/Clinical Reporting training • Global collaboration across Europe and JPAC