Senior Director Biostatistics - Infectious Diseases

Proclinical is seeking a Senior Director of Biostatistics. This role will be a key player in the cross-functional clinical study teams. The successful candidate will provide statistical guidance, carry out sample size calculations, run the creation of plans for statistical analysis and oversee outsourced statistical activities. This role also involves potential line management responsibilities and the opportunity to contribute to departmental strategies.

Responsibilities:

• Work alongside statistics in clinical study teams and projects.
• Serve as the biostatistics lead for assigned programs
• Provide statistical guidance into clinical development plans, study protocols, reports, regulatory submission documents, and publications
• Perform and verify sample size calculations
• Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
• Participate in planning for health authority meetings and development of associated documents
• Oversee outsourced statistical CRO activities and deliverables
• Support and participate in the development of departmental strategies and cross-functional initiatives
• Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
• Work closely with Clinical Data Manager to ensure data quality standards are met

Key Skills and Requirements:

• PhD or Masters in BioStatistics, Mathematics or another equivalent field
• Working experience in the pharmaceutical industry
• Experience in overseeing statistics staff and representing Biostatistics in a multidisciplinary team.
• Knowledge in planning, creating and analysing trials from phase I-IV, including scientific publications
• Proven history knowledge to answer health authority questions (FDA, EMA) and leading in statistics on regulatory submissions
• Knowledge of clinical development, study designs, advanced statistical methods, regulatory guidelines (ICH, FDA, EMA)
• Knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
• Understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
• Excellent analytical skills and communication skills
• Proficiency in both written and spoken English

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

Apply Now:

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.

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.