Biometrics - Director/Senior Director

Location
San Diego, California
Posted
Aug 29, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

MEI Pharm, Inc., a is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. Our portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor that is being developed in combination with azacitidine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Our clinical development pipeline also includes ME-401, a highly selective, oral PI3K delta inhibitor, voruciclib, an oral, selective CDK inhibitor, and ME-344, a novel mitochondrial inhibitor. MEI currently has an open position for a:

BIOMETRICS  -  DIRECTOR / SENIOR DIRECTOR

Job Summary: 

The primary responsibilities of the Director/Senior 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 Development, the Director/Senior 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: 

  • Create and develop Biometrics function at MEI Pharma
  • Provide expertise and guidance to the Clinical Development Team regarding statistical methods for clinical trials 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
  • Review IWRS instructions and plans
  • 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 of Biometrics vendors
  • Lead and manage Biometrics vendors
  • Plan and manage Biometrics related submission activities
  • Lead verification of statistical outputs, data sets used and statistical results in regulatory documents and other clinical data reports, manuscripts and abstracts
  • Familiarity with CDISC and Biometrics Related Guidelines
  • Represent the company Biometrics function at FDA/EMA or other regulatory meetings

Requirements:

  • PhD or Masters 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 required
  • 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

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.