Please note that this position can be filled at either the Sr. Director level or the Director level. The Clinical Biostatistics Director/Senior Director and Head of the Respiratory, Inflammation and Autoimmune (RIA) Therapeutic Area (TA) provides expert and independent statistical team leadership in support of drug development activities and decision making. This includes guidance on appropriate and innovative statistical methods; study design and interpretation of results; strategic input into clinical development planning; and management of Analysis and Reporting (A&R) deliverables.
Lead and develop a team of high performing Clinical Biostatisticians in support of the RIA Therapeutic Area to meet corporate regulatory, scientific, and business objectives.
Participate in the design, conduct, analysis and interpretation of clinical studies and research projects.
Prioritize and manage A&R deliverables in support of CSRs and regulatory submissions within a highly dynamic environment.
Apply statistical techniques to facilitate better decision making and improve business operations.
Provide oversight of statistical and strategic content in support of regulatory interactions.
Effectively interact with senior managers and executives with respect to strategic planning to ensure optimized clinical development.
Influence the broader organization with respect to statistically grounded scientific evaluation of evidence.
Innovate at the speed of technology to identify and implement emerging new ways of doing clinical development as appropriate.
Maintain external awareness and engagement regarding the Clinical Biostatistics and RIA space.
Effectively coordinate statistical endeavors with outside organizations, CROs and consultants.
Participate in establishment and development of department SOPs.
Serve on the Clinical Biostatistics and Data Management Leadership Team.
MS or PhD in statistics or other related field with high statistical content.
Minimum of 10 years of Biotech or Pharmaceutical industry experience with at least 5 in a management capacity. (Director)
Minimum of 13 years of Biotech or Pharmaceutical industry experience with at least 5 in a management capacity. (Senior Director)
Deep understanding of the RIA disease areas.
Experience in regulatory interactions and submissions.
Extensive knowledge of GCP and other relevant ICH/regulatory guidelines.
Demonstrated experience leading and/or building a Clinical Data Management group and/or function.
Comprehensive knowledge of the pharmaceutical industry and drug development process.
Demonstrated ability to drive a vision through to execution and associated change management.
Excellent strategic thinker with the ability to influence others.
Commitment to do the right thing.
Willingness to challenge the organization in good faith.
Ability to compromise with flexibility or hold the line with discipline, along with the judgment required for either on a case by case basis.
Excellent communications skills and ability to articulate the rationale behind statistical principles and the value they bring to the organization. Ability to negotiate effectively.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation
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MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer