Associate Director / Director of Biometrics

Apsida Life Science
1 year ago
Applications closed

Related Jobs

View all jobs

Associate Director, Patient Engagement

Associate Director, Biostatistics

Associate Director, Biostatistics (4)

Associate Director, Case Management Intake & Submissions

Associate Director, Clinical Operations Lead

Associate Director Site Mgt & Oversight Lead (Remote)

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

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

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

Industry Insights

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

Jobs

CSL Behring Jobs UK: Careers, Salaries, Locations & How to Get Hired

CSL Behring is one of the world’s leading biopharmaceutical companies specialising in plasma-derived therapies, recombinant proteins, gene therapy, vaccines, and rare disease treatments. If you’re a UK job seeker looking for a career with real purpose, strong scientific standards, and long-term progression, CSL Behring roles can be an excellent fit, especially if you have experience in biotech, pharma manufacturing, quality, engineering, supply chain, clinical operations, regulatory, pharmacovigilance, or commercial. This guide is written for UK candidates who want to understand what CSL Behring jobs typically involve, which roles to target, where opportunities may be based, what skills recruiters look for, and how to tailor your application to stand out.

Careers

How Many Biotechnology Tools Do You Need to Know to Get a Biotech Job?

If you are trying to break into biotechnology or progress your career, it can feel like the list of tools you are expected to know is endless. One job advert asks for PCR, another mentions cell culture, another lists bioinformatics pipelines, automation platforms or GMP systems. LinkedIn makes it worse, with people sharing long skills lists that make you wonder if you are already behind. Here is the reality most biotech employers will not say out loud: they are not hiring you because you know every tool. They are hiring you because you understand biological systems, can work accurately and safely, follow protocols, interpret results and contribute reliably to a team. Tools matter, but only when they support those outcomes. So how many biotechnology tools do you actually need to know to get a job? The answer depends on the role you are targeting, but for most job seekers it is far fewer than you think. This article breaks down what employers really expect, which tools are essential, which are role-specific, and how to focus your learning so you look employable rather than overwhelmed.

Jobs

What Hiring Managers Look for First in Biotechnology Job Applications (UK Guide)

Hiring managers in biotechnology do not start by reading your CV word for word. They scan for credibility, relevance and risk. In a regulated, evidence-driven sector like biotech, the first question is simple: is this person safe, competent and genuinely capable of contributing in this environment? Whether you are applying for roles in research, manufacturing, quality, regulatory, clinical, bioinformatics or commercial biotech, the strongest applications make the right signals obvious in the first 10–20 seconds. This in-depth guide explains exactly what hiring managers in UK biotechnology look for first, how they assess CVs, cover letters and portfolios, and why capable candidates are often rejected. Use it as a practical checklist before you apply.

🍪 We use cookies to enhance your browsing experience on our website. By continuing to use this site, you consent to the use of cookies as described in our Cookie Policy. You can review our Cookie Policy for more information.