Proclinical is seeking an Associate Director Biostatistics to join a dynamic team in London, UK. This hybrid role offers the opportunity to work on innovative clinical trials in the rare disease space, contributing to the development of groundbreaking therapies. You will collaborate with cross-functional teams, oversee statistical activities, and play a key role in shaping trial designs and data analysis.

Responsibilities:

• Represent biostatistics in cross-functional team meetings to support clinical development plans.
• Collaborate with Clinical Development, Regulatory, and Clinical Operations teams to design clinical trials.
• Author statistical sections of clinical trial protocols and analysis plans.
• Oversee the design of electronic case report forms (eCRFs) in collaboration with Data Management.
• Provide statistical guidance during the conduct of ongoing trials.
• Work with Statistical Programmers to summarize and analyze trial data.
• Contribute to clinical study reports and regulatory documents such as DSURs and briefing documents.
• Represent the organization in meetings with regulators, key opinion leaders, and other stakeholders.
• Support the preparation of scientific articles summarizing trial data.
• Consult with preclinical and research teams on statistical questions.
• Manage CRO statistical and programming support.

Key Skills and Requirements:

• Advanced degree (PhD or MS) in Biostatistics, Statistics, or a related field.
• Proficiency in SAS programming and familiarity with R programming.
• Strong written and oral communication skills.
• Experience with CDISC standards, including SDTM, ADaM, and CDASH.
• Knowledge of ICH GCP guidelines and industry practices.
• Experience designing adaptive trials and working through Phase 3 and NDA submissions.
• Ability to represent sponsors in regulatory meetings.
• Interest in biology and biological processes, including RNAi therapeutics.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com.

Apply Now:

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy