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- Tasks: Lead biostatistics for clinical studies and manage biometrics vendors.
- Company: Apsida Life Science is a growing company focused on innovative clinical programs.
- Benefits: Enjoy a hybrid working model with the option for fully remote work.
- Why this job: Join a dynamic team shaping the future of drug development in oncology.
- Qualifications: 10+ years in biostatistics, preferably in early-phase oncology, with strong SAS programming skills.
- Other info: Reach out to Jamie Salmon for a confidential chat about this exciting opportunity.
The predicted salary is between 72000 - 108000 £ per year.
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:
- Data management and statistical methodologies.
- Planning and budgeting for data management and analysis in complex clinical trials, including data handling within electronic data capture platforms.
- Managing contract vendors for data management, programming, and statistical activities.
- 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.
Jamie.salmon@apsida.com
www.apsida.co.uk
Associate Director / Director of Biometrics employer: Apsida Life Science
Contact Detail:
Apsida Life Science Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director / Director of Biometrics
✨Tip Number 1
Make sure to highlight your extensive experience in biostatistics, especially if you have worked in early-phase oncology. This is a key requirement for the role, and showcasing relevant projects can set you apart.
✨Tip Number 2
Demonstrate your leadership skills by discussing any previous experiences where you managed teams or collaborated with cross-functional groups. This will show that you can effectively lead and work within diverse teams.
✨Tip Number 3
Familiarize yourself with CDISC standards and regulatory submission processes, as these are crucial for the role. Being able to discuss your knowledge and experience in these areas will be beneficial during discussions.
✨Tip Number 4
Prepare to talk about your proficiency in SAS programming and how you've applied it in past projects. Providing specific examples of your work can demonstrate your technical expertise and problem-solving abilities.
We think you need these skills to ace Associate Director / Director of Biometrics
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Associate Director / Director of Biometrics position. Familiarize yourself with the key tasks such as statistical analysis plans, SAS programming, and clinical study design.
Tailor Your CV: Customize your CV to highlight relevant experience in biostatistics, particularly in pharmaceutical or biotechnology settings. Emphasize your leadership roles and any specific projects related to oncology studies or regulatory submissions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for biostatistics and your strategic vision for the role. Mention your experience with CDISC standards and your ability to lead teams effectively, aligning your skills with the company's needs.
Highlight Relevant Skills: In your application, clearly outline your expertise in statistical methods, data management, and SAS programming. Provide examples of how you've successfully managed complex clinical trials and collaborated with cross-functional teams.
How to prepare for a job interview at Apsida Life Science
✨Showcase Your Statistical Expertise
Be prepared to discuss your advanced knowledge of statistical methods and how you've applied them in previous roles. Highlight specific examples where you independently designed studies or tackled complex statistical challenges.
✨Demonstrate Leadership Skills
Since the role involves leading teams, share experiences that showcase your leadership abilities. Discuss how you've managed external teams and ensured high-quality outputs within timelines.
✨Familiarize Yourself with CDISC Standards
Given the importance of CDISC standards in this role, make sure you understand these guidelines thoroughly. Be ready to explain how you've implemented these standards in past projects.
✨Prepare for Cross-Functional Collaboration
This position requires collaboration with various departments. Think of examples where you've successfully worked with cross-functional teams, particularly in clinical operations or regulatory affairs, and be ready to discuss them.
