Senior Director, Biostatistics
The Senior Director will provide statistical leadership and expertise in support of the clinical development and post‐marketing activities for multiple therapeutic areas.
The senior director will be responsible to contribute strategically to project decisions with a focus on pre‐ study planning, protocol development, study designs including sample size/power calculations, Statistical Analysis Plan preparation/review, data quality reviews, development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission, and integrated safety and efficacy reporting.
The senior director will also apply innovative statistical approaches to the work (e.g, modeling and simulation, adaptive design/Bayesian statistics); support and defend analyses and their interpretations in meetings and teleconferences with regulatory agencies and prepare written responses to agency inquiries.
It is imperative that the senior director to partner with project teams and other Development functions including Regulatory, Clinical Science, Clinical Operation, Clinical and Statistical Programming, Data Management, Medical Affairs, Medical Writing.
Duties and Responsibilities
The duties and responsibilities include but are not limited to the following:
- Responsible for leading the Biostatistics platform for assigned projects in ensuring effective, timely, high quality and compliant management and delivery of project goals and Provide expert statistical input and consultancy to Phase I – IV global clinical trials, lifecycle management activities as well as Translational Medicine research efforts
- Actively participate in project teams as the Biometrics Interacts strategically with cross‐ functional teams and other functional areas to ensure timely project deliverables; maintains consistently high performance standards and quality of work and ensure all clinical development programs meet scientific, regulatory, quality and commercialization requirements
- Provides strategic thinking and statistical expertise to define the right questions to be answered in the design of clinical trials; specifically contributes from a statistical perspective to the creation of the Clinical Development Plans
- Plan, direct and organize all statistical activities for the assigned products including study protocol development, statistical methodology, data analysis and interpretation, and make sure clinical trials are optimally designed, properly analyzed and clearly presented to support new product development, regulatory submissions and the maintenance and growth of existing products
- Incorporates cost, time, risk/opportunity, benefit to subjects and probability of success into statistical analysis, synthesis and recommendations to the project team
- Ensure the Biostatistics efforts conducted are technically sound and of high quality
- Responsible for the overall quality of all statistics /SAS programming design, analysis and reporting deliverables for global Phase I‐IV and Translational Medicine research efforts
- Provides specific functional expertise and leadership within Biostatistics
- Support the head of Biometrics to plan statistical resources to deliver on project
- Collaborate with the head of Biometrics and other project statisticians so that activities are aligned with company goals; standards and processes are consistent across all therapeutic areas
- Lead in development and adaptation of new statistical methodology in support of Theravance Biopharma drug development
- Participate in establishing and maintaining policies, standards and guidance for Biostatisticsl operations
- Determine efficient utilization of Biostatistics resource by leveraging both in‐house staff and outside Provide input on optimal resource utilization and capacity
- Manage outside statistical CROs and consultants as needed, maintain constant and open communication to make sure timely and quality deliverables
- Oversee projects which relate to improving the quality of science and its implementation within the Theravance Biopharma development or
- A PhD in statistics or biostatistics with minimum 12 years of clinical development experience in the pharmaceutical/biotech industry
- Proficiency with statistical analysis software such as SAS or R
- Solid understanding of clinical trial principles and regulatory requirements
- Knowledge of industry data standards
- Effective verbal and written communication and strong interpersonal skills
- Demonstrated ability to work in a team environment
- Must be flexible and work well within a dynamic, interdisciplinary, small company environment requiring multi‐tasking and changing priorities
- Experience with regulatory interactions
- Dynamic self‐starter; agile learner; strategic and creative thinker
- Demonstrated strong problem solving and risk‐mitigation skills
This position may or may not have any direct reports but it is expected that this position will be highly effective at managing and coordinating Biometrics efforts within the assigned projects for the purposes of achieving project goals. This position will be expected to work with the head of Biometrics for resource needs including development of internal staff.