Associate Director of Biostatistics

My client, a global pharmaceutical company based in West Dublin is actively looking for an Associate Director of Biostatistics to join their team. This is a full time, permanent position.

Your Role:

As Associate Director of Biostatistics you will provide leadership and guidance as the statistical expert on project teams or within a therapeutic area.  He/she is accountable for all statistical aspects of assigned clinical studies including trial design, protocol development, analysis and interpretation of results for publications and submissions.   

Key Responsibilities:

• Responsible for cross functional participation in study design, clinical protocol development, statistical methodology and modeling, sample size estimations, endpoint specification, study logistics, randomization plans, interim analyses, and statistical analysis plans.
• May be the statistical member of Data Safety Monitoring Committee to assess product safety.
• Responsible for execution of statistical analysis, statistical programming procedures and production of tables, listings and figures either directly or through management of CRO’s.
• Reviews and participates in Quality Control of publications, reports, regulatory documents. May collaborate other statisticians and or programmers to ensure quality assurance of data outputs.
• Authors statistical sections of protocols, reports, manuscripts and regulatory documents.
• Represents Company as a statistical expert at international regulatory agency meetings to support rationale and questions of statistical plans /methodologies for how data is planned to be or has been analyzed. 
• Member of therapeutic area Adboards and Publication Planning teams on future or current clinical programs.
• Responsible for incoming data from various sources (i.e.. Pharmacokinetic data) outside of Electronic Data Capture and will oversee with support from other biometry functions quality checks and integration into data tables through to final analysis.
• Supports the biometry department with drafting SOP revisions or process efficiencies.
• Ensures processes, SOPs, documentation and GCP/ICH adherence for statistical activities.

Education, Knowledge, Skills and Abilities:

• PhD or MS degree in statistics biostatistics, mathematics or related field

• Ideally 10-12 years of experience in biostatistics in the biotechnology, pharmaceutical, Clinical or health related industry including significant interactions with regulatory bodies. 

• Expert knowledge of a wide range of statistical methodology, including experimental design, linear models, mixed models, categorical data techniques, nonparametric statistics, and survival analysis. Expert knowledge of advanced statistical and probability theory.  Expert knowledge of regulatory guidelines related to trial design, analysis, reporting, data structure, and electronic submissions. Broad knowledge of clinical trials and the statistical applications in clinical trials. Strong knowledge of ICH GCP and FDA guidelines. Broad knowledge of medical background to be able to communicate with medical personnel regarding the statistical issues arising in the clinical trials. Solid skills in computer programming (especially SAS). Excellent interpersonal communication skills (verbal and written) in English.  Ability to interact effectively with non-statistical colleagues on project teams. Ability to defend statistical methodology to regulatory agencies. Must have strong computer system skills with a proficiency in Microsoft applications (Word, Excel) programming languages/data visualization tools (e.g., SAS, Java, C++, J-Review, Spotfire, Tableau) and relational databases (SQL, PL/SQL etc.)

If you are interested in applying for this role or discuss the position in more detail, please call Tina on +353 1 2784701 or 0876811990 or email tdunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading provider of specialist Scientific Recruitment. A specialist division of the CPL Group. www.thornshaw.com