Executive Director, Biometrics

Job Summary: 

The primary responsibilities of the Executive Director, Biometrics, are to ensure systems, capabilities and resources are in place that optimize the design, conduct, analysis, and interpretation of clinical data for all MEI Pharma clinical programs.  In this leadership position within Clinical Research & Development, the Executive Director, Biometrics, manages all operational aspects of biostatistics, data management and statistical programming, either directly with MEI Pharma personnel or indirectly with consultants and clinical research organizations (CRO) personnel.  This position provides leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results.

Responsibilities: 

Strategic role

• Grow and enhance Biometrics function at MEI Pharma
• Management oversight for the leaders of biostatistics, data management, and statistical programming functions
• Represents the Biometrics function within the MEI Pharma Clinical R&D leadership team
• Represents the Biometrics function at the MEI Pharma senior leadership level
• Responsibility for developing and managing the Biometrics budget
• Represent the Biometrics function at FDA/EMA or other regulatory meetings

Operational role

• Provide expertise and guidance to Clinical Development and Medical Affairs regarding statistical methods for clinical trial design and trial data analyses
• Participate in the protocol development process, including responsibility for sample size and power calculations, and write/review statistical section of reports/protocols
• Active member of protocol development core team providing input in design, outcome measures, and endpoints assessment
• Responsible for the oversight and/or preparation of the Statistical Analysis Plan (SAP), including the resulting tables, figures, and listings for inclusion in the clinical study report (CSR), integrated summary documents and/or publications
• Responsible for the oversight of the development of SAS programs, either directly or indirectly via CROs, to perform planned or ad hoc analyses and prepare data displays
• Identify, participate in the evaluation/selection and oversight of Biometrics vendors
• Plan and manage Biometrics related regulatory submissions
• Develop SOPs related to data management and biostatistics
• Lead verification of statistical outputs, data sets used and statistical results in regulatory documents and other clinical data reports, manuscripts, and abstracts

Requirements:

• PhD in statistics or biostatistics
• Minimum of 7 years of biostatistical, data management and clinical programming experience in the pharmaceutical or biotechnology industry
• Oncology experience preferred
• Strong analytical skills and demonstrated experience in gathering, interpreting, and analyzing data in clinical research and drug development
• Extensive knowledge of clinical research methodology and regulatory requirements as they related to trial design and analysis
• Solid scientific background and understanding of clinical trials, clinical development operations and regulatory compliance.
• Ability to effectively contribute to the statistical aspects of clinical protocol design, data interpretation, review and reporting of results for multiple studies and projects
• Experience in managing Biostatistics, Data Management, Statistical Programming, and overall resource planning
• Good knowledge of ICH, FDA, and GCP regulations and guidelines; strong well-rounded technical skill, SAS, SDTM, ADaM, and CDISC
• Prior experience with regulatory submissions
• Prior successful NDA and/or IND submission preferred
• Solid knowledge and experience in drug development process
• Adept at outsourcing and managing biostatistical services provided by CROs and contractors
• Strong leadership and must be able to collaborate and work with other departments such as Clinical, Finance, Research & Regulatory Affairs
• Ability to work in a fast-paced environment
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
• Excellent organizational communication skills
• Ability to prioritize effectively to deliver results within reasonably established timelines
• Able to thrive in a small group setting, possesses high energy hands-on attitude

Personal Characteristics & Cultural Fit

• Ability to work in a fast-paced environment
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
• Excellent organizational communication skills
• Ability to prioritize effectively to deliver results within reasonably established timelines
• Able to thrive in a small group setting, possesses high energy hands-on attitude

ADA Notations:

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
• Regular communication (hearing/speaking)
• Routine office duties including computer keyboard use and some lifting of light-weight office equipment and files as needed
• Vision requirements include close vision and ability to focus
• Noise conditions range from quiet to moderate.