Associate Director Biostatistics

Proclinical Staffing; London; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

A leading life sciences recruitment firm is seeking an Associate Director of Biostatistics to join their London team. This hybrid role focuses on innovative clinical trials within the rare disease space, requiring an advanced degree and proficiency in SAS. Responsibilities include cross-functional collaboration, overseeing statistical activities, and contributing to trial designs and data analysis. The ideal candidate will have strong communication skills and experience with industry standards.

Qualifications

• Advanced degree (PhD or MS) in Biostatistics, Statistics, or a related field.
• Proficiency in SAS programming and familiarity with R programming.
• Experience with CDISC standards and knowledge of ICH GCP guidelines.

Responsibilities

• Represent biostatistics in cross-functional team meetings.
• Collaborate with teams to design clinical trials and author statistical sections.
• Oversee the design of electronic case report forms and provide statistical guidance.

Skills

SAS programming

R programming

Strong written and oral communication skills

Knowledge of ICH GCP guidelines

Interest in biology and biological processes

Education

PhD or MS in Biostatistics, Statistics, or a related field

Job description

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 [e-mail].

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