Associate Director / Director of Biometrics

Apsida Life Science
Manchester
2 weeks ago
Create job alert

Job title: Associate Director / Director of Biometrics

Reporting into: Lead Physician

Location: UK, hybrid working model preferred, fully remote considered


Apsida Life Science are currently looking to appoint a Associate Director / Director of Biometrics to grow a newly formed stats department.


You will ne responsible for providing strategic guidance on statistical methods and data management activities for clinical programs. Responsibilities include developing and reviewing statistical analysis plans, conducting SAS® programming for descriptive and inferential analysis, and offering statistical support for the writing of clinical protocols and clinical study reports for our clients-sponsored or managed clinical trials. Additionally, you will lead the provision of scientific advice on statistical approaches for clinical study design.


Responsibilities:

  • Serve as the lead biostatistician on clinical studies as part of the project team.
  • Oversee the selection and management of biometrics vendors supporting sponsored or managed studies, including budgeting, timelines, cost assessments, and contract management.
  • Provide expertise and support in trial design and protocol development.
  • Develop and review statistical analysis plans.
  • Review database setup documents during clinical study setup, such as the Data Management Plan, Case Report Forms, Database Specifications, and Edit Check Specifications.
  • Support data review processes in clinical studies, including Tables/Figures/Listings, Clinical Data Interchange Standards Consortium (CDISC) data (Study Data Tabulation Model [SDTM] and Analysis Data Model [ADaM]), and data submission packages (e.g., define.xml, Pinnacle21, Data Reviewer Guides).
  • Contribute to New Drug Application (NDA) and Market Authorization Application (MAA) documentation, including reviewing clinical study reports.
  • Collaborate closely with cross-functional teams, including Medical, Clinical Operations, Imaging, and Regulatory Affairs.
  • Develop departmental strategies, frameworks, and best practices.
  • Perform other duties as required based on business needs.


Preffered Background:

  • Over 10 years of professional experience, including more than six years in biostatistics within a pharmaceutical or biotechnology company, with a preference for early-phase oncology experience.
  • Advanced expertise in statistical methods for innovative trial design and analysis, with a demonstrated ability to independently design and oversee studies while addressing complex statistical challenges.

Extensive experience in:

  1. Data management and statistical methodologies.
  2. Planning and budgeting for data management and analysis in complex clinical trials, including data handling within electronic data capture platforms.
  3. Managing contract vendors for data management, programming, and statistical activities.
  4. Regulatory submissions and interactions, including phase III trial management, NDA/MAA submissions, and compliance with data submission standards.
  • Comprehensive knowledge of CDISC standards.
  • Deep understanding of the drug development process, including regulatory filing experience.
  • Familiarity with the full process flow from database build initiation to go-live, as well as the steps involved in data migrations.
  • Experience in designing and reviewing Case Report Forms (CRFs) for oncology studies.
  • Strong understanding of budget development for data management activities.
  • Proficiency in SAS programming concepts, best practices, and techniques related to drug development.
  • Knowledge of Good Clinical Practice (GCP) regulations and requirements.
  • Proven ability to effectively lead external teams in delivering high-quality statistical and data management outputs within established timelines.
  • Demonstrated leadership experience in managing teams of statisticians, data scientists, or analytics professionals.
  • Experience in oncology and diagnostic imaging.


If you’re interested in learning more, please reach out to Jamie Salmon, Chief Operating Officer for a confidential chat.


www.apsida.co.uk

Related Jobs

View all jobs

Associate Director / Director of Biometrics

Associate Director of Finance

Quantitative Associate Director - Brand & Design Research

Associate Director Consulting

Policy and Research Advisor

Senior Analytics Manager, Measurement & Insights

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.

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.

Career Paths in Data Science: From Entry-Level Analysis to Leadership and Beyond

Data is the lifeblood of modern business, and Data Scientists are the experts who turn raw information into strategic insights. From building recommendation engines to predicting market trends, the impact of data science extends across virtually every industry—finance, healthcare, retail, manufacturing, and beyond. In the UK, data-driven decision-making is critical to remaining competitive in a global market, making data science one of the most sought-after career paths. But how does one launch a career in data science, and how can professionals progress from entry-level analysts to senior leadership roles? In this comprehensive guide, we’ll explore the typical career trajectory, from junior data scientist to chief data officer, discussing the key skills, qualifications, and strategic moves you need to succeed. Whether you’re a recent graduate, transitioning from another technical field, or an experienced data scientist aiming for management, you’ll find actionable insights on forging a successful career in the UK data science sector.