Director, Biostatistics (FSP - Permanent Homebased)

IQVIA, Inc.
Reading
1 month ago
Applications closed

Related Jobs

View all jobs

Associate Director / Director of Biometrics

Associate Director / Director of Biometrics

Lead Clinical Scientist

Lead Clinical Scientist

Lead Clinical Scientist

Senior Scientist, Pharmacoepidemiology & Safety

Job Overview:

As Biostatistics Director, you will liaise with cross-functional teams to drive the quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.

Key Responsibilities:

Leadership:

  1. Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company.
  2. Represent sponsors at meetings with regulatory agencies or other regulatory meetings; may participate as a member of a Data and Safety Monitoring Committee.
  3. Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication.
  4. Participate as high-level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries, and/or NDA sections.
  5. Lead studies at an operational level.
  6. Provide expert review and initiate methodology development work regarding statistical standards and validation procedures.
  7. Consult on operational/statistical/therapeutic area topics.


Knowledge Sharing:

  1. Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact analyses.
  2. Perform as subject matter expert (SME).


Risk Management:

  1. Identify risks to project delivery and/or quality, leading in a way to minimize risks.
  2. Anticipate risks to avert the need for study-level escalations, supporting leads in implementing risk mitigation actions.


Lock and Unblinding Process:

  1. Lead the database lock and unblinding process for the statistical team.
  2. Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules).


Statistical Expertise:

  1. Provide expert statistical input into the review of statistical deliverables (i.e., statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports).
  2. Provide expert input into data management deliverables (i.e., database design, CRF design, validation checks, and critical data).
  3. Provide expert review of ADaM reviewers guide (ADRG) and metadata.
  4. Perform senior biostatistical review (SBR).
  5. Produce or perform quality control review of sample size calculations for complex studies.


Requirements:

  • Masters or PhD degree in Biostatistics or a related field and 10+ years' relevant experience within the life-science industry.
  • Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials.
  • Expert in strategically collaborating with clinical and drug development experts.
  • Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries.
  • In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines.
  • Strong working knowledge of SAS or R.
  • Excellent knowledge of CDISC Data Standards.
  • Superb communication and collaboration skills.
  • Independent and pro-active problem-solving skills.
  • Rare disease and immunology experience is greatly preferred.

#J-18808-Ljbffr

Get the latest insights and jobs direct. Sign up for our newsletter.

By subscribing you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

10 Essential Books to Read to Nail Your Data Science Career in the UK

Data science continues to be one of the most exciting and rapidly evolving fields in tech. With industries across the UK—ranging from finance and healthcare to e-commerce and government—embracing data-driven decision-making, the demand for skilled data scientists has soared. Whether you're a recent graduate looking for your first role or a professional aiming to advance your career, staying updated through books is crucial. In this article, we explore ten essential books every data science job seeker in the UK should read. Each book provides valuable insights into core concepts, practical applications, and industry-standard tools, helping you build skills employers are actively looking for.

Navigating Data Science Career Fairs Like a Pro: Preparing Your Pitch, Questions to Ask, and Follow-Up Strategies to Stand Out

Data science has taken centre stage in the modern workplace. Organisations rely on data-driven insights to shape everything from product innovation and customer experience to operational efficiency and strategic planning. As a result, there is a growing need for skilled data scientists who can analyse large volumes of data, build predictive models, communicate findings effectively, and collaborate cross-functionally. If you are looking to accelerate your data science career—or even land your first role—attending data science career fairs can be a game-changer. Unlike traditional online applications, face-to-face interactions let you showcase your personality, passion, and communication skills in addition to your technical expertise. However, to stand out in a busy environment, you need a clear strategy: from polishing your personal pitch and asking thoughtful questions to following up with a memorable message. In this article, we’ll guide you through every step of making a strong impression at data science career fairs in the UK and beyond.

Common Pitfalls Data Science Job Seekers Face and How to Avoid Them

Data science has become a linchpin for decision-making and innovation across countless industries, from finance and healthcare to tech and retail. The demand for data scientists in the UK continues to climb, with businesses seeking professionals who can interpret complex datasets, build predictive models, and communicate actionable insights. Despite this high demand, the job market can be extremely competitive—and many applicants unknowingly fall into avoidable traps. Whether you’re an aspiring data scientist fresh out of university, a professional transitioning from a quantitative role, or a seasoned analyst looking to expand your skill set, it’s crucial to navigate your job search effectively. In this article, we explore the most common pitfalls data science job seekers face and provide pragmatic advice to help you stand out. By refining your CV, portfolio, interview strategies, and communication skills, you can significantly increase your chances of landing a rewarding data science role. If you’re looking for your next data science job in the UK, don’t forget to explore the listings at Data Science Jobs. Read on to discover how to avoid critical mistakes and position yourself for success.