Associate Director / Director of Biometrics

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