Director Executive Director Biostatistics North Carolina
Full-time Position. Must be able to work on-site in NC
You can apply for the position directly to this post at the bottom of the page.
As head of Biostatistics, this individual is responsible for the planning and delivery of all statistical activities required to support the highest quality design, conduct, and analysis of sponsored studies. Having both technical and vendor management responsibilities, this role is responsible for the appropriate use of statistical thinking and methods, and conformance to principles of GCP, as applicable to biostatistics and clinical data management. S/he is also responsible for the identification, evaluation, and implementation of new processes and technologies that align Biostatistics responsibilities with the goals of the Clinical Development organization. Performance in this role relies on an extensive experience base in study design, regulatory strategy and programming, sound judgment to plan and accomplish goals, and an ability to lead and direct the work of others. A wide scope of creativity and latitude is expected.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Ensures the relevance and adequacy of statistical methods employed in all -sponsored clinical development activities and selected nonclinical studies.
* Ensures clinical data processing conformance to relevant regulatory guidelines and Good Clinical Practice.
* Effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design.
* Selection, direction, and supervision/management of CRO/ contract staff for the performance of outsourced operational activities.
* Utilizes statistical software (SAS, PASS) for internal ad hoc requests for data analysis, samples sizes, etc.
* Participation in clinical development/product management teams in support of organizational objectives.
* Participation in FDA and other regulatory agency meetings as the Company’s spokesperson for biostatistical topics
* Thinks outside of the regulatory biostatistics box (e.g. maximum learning from phase 2 experiments regardless of pre-specified SAP, experience in Phase 3b/4 design and analysis to maximize a product’s life cycle).
* Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement.
* Definition, monitoring, and evaluation of relevant performance metrics.
* Author/ reviewer of relevant sections of all critical documents required to support the development of Company’s products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts and manuscripts.
* Responsible and accountable for the accuracy of all data included in public corporate communications of clinical trial results, including press releases, slide presentations, SEC filings, scientific meeting abstracts, and published manuscripts. Responsible for monitoring of quality audit process for those communications.
* Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor.
* Ph.D. in Biostatistics (or related field) with at least 12 years experience in the pharmaceutical industry, 10 or more years experience in the design, analysis, and interpretation of clinical trials. Incumbent must also have deep and recent SAS programming experience to support these activities.
* NDA filing experience: key contributor to one or more successful product approvals
* Proven expertise in the disciplines, practices, and procedures that pertain to biostatistics and clinical data management, including development and accountability for relevant quality management systems.
* Demonstrated knowledge of the clinical development process and of relevant regulatory guidelines and requirements
* Experience with Data management committees and\or study steering committees.
* Leadership skills both functional and cross-functional
* Takes a hands-on approach (e.g. will do analyses him/herself when necessary)
* Excellent written and verbal communication skills
* Proven team player with ability to work well in a collegial environment: willing to challenge the status quo
* Experience with European and Japanese regulatory agencies
* Formal expertise and experience in Bayesian statistics as well as frequentist statistics
* Postmarketing safety surveillance, including case-control studies, cohort studies, database analyses, propensity scores, and risk modeling.
* Flexible scheduling and ability to travel internationally
* Small company attitude, embraces change within a high-risk environment
* Responsiveness and ability to prioritize effectively