Hobson Prior is working with a well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire an Associate Director of Statistics. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK. This role will be based in Cambridge on a permanent basis.
As Science Associate Director Biostatistics Oncology, you will provide statistical leadership in support of a compound(s)/product(s) mainly within Oncology. This includes guidance on statistical methods, appropriate study design and interpretation of results; strategic input into clinical development planning; and management of Analysis and Reporting (A&R) deliverables.
• Function as a Global Product Statistician (GPS) by providing comprehensive statistical leadership for a compound(s)/product(s) within a Therapeutic Area (TA).
• Lead the statistical thinking for all aspects of the development process including definition of the target product profile/claim, formulation of go/no-go/futility criteria, evaluation of benefit/risk profile, and development of associated regulatory strategy.
• Demonstrate knowledge regarding disease(s) under study, potential mechanism(s) of action and approval pathways/histories of other current/past drugs.
• Collaborate effectively with Clinical Research colleagues by driving statistical thinking, proper data interpretation and disciplined exploratory data analysis.
• Responsible for statistical sections of Protocol Concept Sheet (PCS), study protocols, Clinical Development Plans (CDPs), and integrated Product Development Plans (iPDPs).
• Lead development of components of regulatory submissions (e.g., FDA briefing documents, response to FDA requests) and represent the company to Health Authorities (e.g., Pre-IND and EOP2 meetings).
• Define and lead the analysis of relevant internal and external information to inform design decisions.
• Responsible for statistical aspects of internal governance reviews.
• Authoring or overseeing authorship of Statistical Analysis Plans (SAPs).
• Authoring or overseeing authorship of Statistical Programming Plans (SPPs).
• Comprehensive knowledge of statistical methods and applications in study design and analysis.
• Ability to innovate creatively in a clinical study design setting.
• Ability to communicate with clarity and influence.
• Knowledge of ICH/EMEA/FDA guidelines.
• Demonstrated ability to serve effectively as a delivery team leader.
• Ability to manage and mentor project statisticians.
• Demonstrated ability to effectively collaborate and influence throughout multiple levels of the organization.
• Experience in regulatory interactions and submissions.
Masters or PhD in statistics or other related Masters or Ph.D. degree program with high statistical content.
Minimum 6 years of industry experience in clinical study environment including lead statistician role at compound level.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life science recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.