Meet with a CSL Behring representative in person at the HireLifeScience.com Career Fair 2017! Register to attend at http://www.hirelifescience.com/career/ The Director Biostatistics TA Lead (TAL) manages a team of statisticians in one or more therapeutic areas. The TAL provides statistical strategies for clinical development programs and regulatory submissions, and is accountable for the statistical deliverables within the responsible areas.
RESPONSIBILITIES AND ACCOUNTABILITIES
•Lead full scope of Biostatistics contributions to the responsible areas. Coordinate with internal and external stakeholders through the Stage Gate process.
•Partner with TA Head and other functional leads within the areas. Influence and contribute to clinical development plans (CDPs/TPPs). Ensure full integration of statistical strategy and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
•Ensure sound statistical foundation underpinning program strategy within the responsible area. Be accountable for the quality of statistical strategy and analysis planning for clinical trials and regulatory submissions.
•Represent Biostatistics in interactions with authorities, including FDA, EMA, PMDA, etc.
•Provide statistical leadership dealing with concepts and complexity comfortably. Interact effectively with senior management and external KOL.
•Coordinate priorities and monitor outsourcing operations within the responsible areas. Ensure timeliness and quality of deliverables by CRO.
•Manage the Biostatistics team to achieve corporate and department goals. Provide technical statistical expertise, leadership and serve as a role model and mentor to staff. Mentor staff and cultivate professional growth.
•Extend influence and leadership across functions. Identify and lead opportunities for infrastructure / process / scientific consulting improvement initiatives and related standards
Reports To: Head of Global Biostatistics and Statistical Programming
Direct Reports: Statisticians and/or statistical programmers
PhD or MS in Biostatistics, Statistics, or related fields
•10 years of experience in Clinical Development in a Pharmaceutical or Biotechnology setting
•Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
•Significant experience in interactions with major regulatory authorities and regulatory submissions
•Experience managing people preferred
•Experience managing CRO preferred
•Track record of innovation desired
•Broad knowledge of statistical theories and applications of advanced statistical methodologies
•Broad knowledge of clinical development and processes
•Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management
•Ability to collaboratively work and provide leadership in matrix environment
•Strong problem solving skills
•CDISC, statistical programming, and/or data standards
•Biostatistics and Statistical Programming Operations
• As needed
Worker Sub Type: