Sr. Director/Director, Biostatistics and Data Management - Newark, CA | Biospace
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Sr. Director/Director, Biostatistics and Data Management

Revance Therapeutics, Inc.

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Location:
Newark, CA
Posted Date:
8/7/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Biostatistics, Clinical Data Management, Director,

Job Description


In this leadership position, the Senior Director/Director, Biostatistics and Data Management will manage all operational aspects of Biostatistics and Data Management supporting drug development activities and clinical decision making. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results and will be a key member of the Clinical Development Leadership Team.

Essential Functions:

•   Provide expertise and guidance to the Clinical Development Team regarding statistical methods for data analyses of clinical trials.
•   Provide statistical representation and leadership on project and protocol teams and to regulatory agencies.
•   Participate in the protocol development process, including responsibility for sample size/ power calculations and the statistical section of the protocol.
•   Responsible for preparation of the Statistical Analysis Plan (SAP), including the resulting tables, figures, and listings for inclusion in the clinical study report (CSR) and/or publications.
•   Develop SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays.
•   Lead verification of statistical programs, data sets used and statistical results in regulatory documents and other clinical data reports.
•   Participate in the writing, review, and finalization of regulatory documents, CSRs, abstracts, and manuscripts for publication.
•   Participate in regulatory preparation activities including document authorship (e.g. NDA, sNDA), and answering requests from the FDA
•   Provide statistical interpretation and explanation of results to team members.
•   Work collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of day to day biostatistics deliverables.
•   Establish best in class processes and standards for the generation and reporting of data.
•   Build and lead team of high performing Clinical Biostatisticians to meet corporate regulatory, scientific, and business objectives.
•   Lead team in the design, and analysis of clinical studies using appropriate and innovative statistical methods.
•   Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
•   Identify and implement emerging new ways of doing clinical development and new methodologies.
•   Lead development of department SOPs.
•   Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines.
•   Contribute to project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Operations management.

Requirements


Preferred Experience:

•   7 to 10 years of experience in clinical development research.
•   Must have expert knowledge and experience in biostatistical theory, analysis and computer science.
•   Strong methodological capabilities and broad drug development experience. Experience with regulatory submissions, project and proposal management experience are relevant qualifications for this position. SAS experience is a requirement.
•   Demonstrated ability to effectively contribute to the statistical aspects of clinical protocol design, data interpretation, review and reporting of results for multiple studies and projects.
•   Prior successful NDA and IND filing experience required.
•   Adept at outsourcing and managing biostatistical services provided by CRO's and contractors.
•   Extensive experience interacting with regulatory agencies, both US and ex-US.
•   Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development.
•   Experience in managing Biostatistics and Data Management and overall resource planning.

Preferred Education:

•   M.S. or Ph.D. in Statistics or Applied Mathematics

Preferred Additional Skills:

•   Excellent interpersonal and communication skills, both verbal and written.
•   Consummate team player with excellent collaboration skills.
•   Ability to communicate statistical information to non-scientists, and willingness to educate internal team.
•   Strong customer orientated awareness and focus; strives to support others to succeed.
•   Pronounced quality focus.
•   Advanced computer skills including spreadsheets, word processing database management and specialized statistical software packages with emphasis on strong skills using Statistical Analysis System (SAS) software.
•   Strong leadership skills with ability to influence decisions and achieve results.
•   Ability to adjust to multiple demands, shifting priorities, and unexpected events while maintaining a positive work attitude.