Senior Manager /Associate Director of Biostatistics
Nurix has a place for an extraordinary, highly motivated, self-starter and accomplished Sr. Manager/Associate Director of Biostatistics to become a part of growing biometrics organization.
Position
The Sr. Manager/Associate Director of Biostatistics will provide subject matter expertise for planning and be accountable for the clinical study related deliverables for Nurix clinical development programs. The successful candidate will have responsibility for strategy and operational activities, as well as assisting the Head of Biostatistics in the development and implementation of departmental policies, operational guidelines, and administrative structure. The successful candidate will also serve as senior specialist within Clinical Development and within the field of clinical trial design, data science, statistical methodology and application. The candidate should have a successful and progressive track record in leading teams and effectively structuring a function to manage the anticipated growth in the product pipeline. The successful candidate must also possess excellent communication skills to interface with senior leadership on behalf of the department and work closely with medical study directors to provide and receive direction on clinical programs and can influence the clinical teams.
Additional key representative responsibilities will include, but not necessarily be limited to, the following:
Job Responsibilities
- Provide statistical expertise to support Global Clinical Development in the organization
- Take analytic leadership role in developing efficient clinical development programs and guide clinical development strategy from an analytical focus
- Support the development and implementation of innovative strategies and technologies for biostatistics
- Proficiency and/or thought leadership in novel methodologies such as Bayesian methodologies, adaptive design, simulation, and statistical modeling
- Stay abreast of emerging technologies and concepts related to applied statistical methodology
- Direct the statistical design, conduct, and analysis of clinical trials in all phases
- Review protocols and case report forms for soundness of trial design
- Author statistical analysis plans for all phases of a trial
- Communicate and collaborate effectively with other clinical development functions (including but not limited to clinical development, clinical operations, translational medicine, safety and pharmacovigilance)
- Perform and/or review the analysis and interpretation of clinical study results, and collaborate with clinical team to produce interim reports, final reports, and publications
- Direct the development, validation and summary of integrated safety and efficacy summary documents for submissions
- Support pre-clinical and research teams on the experimental design, data analysis and statistical modeling activities
- Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets
- Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and work practices
- Develop and implement department standards and practices to ensure statistical integrity of project deliverables
Qualifications
- Advanced degree in statistics, biostatistics, mathematics, computer science or equivalent experience
- Minimum of 6 years (for Sr. Manager or 8 years for Assoc. Director) of progressive experience leading as study/program biostatistician in biotech/pharmaceutical industry
- Experience in all phases of oncology clinical development
- Experience in managing technical professionals in a regulated environment is desirable
- Experience of mentoring and maintaining statistics group in multiple clinical development programs simultaneously
- Significant knowledge of the drug development process, clinical trial methodology, statistics, and relevant regulatory requirements for drug approval
- Experience building and utilizing innovative dynamic reporting and data monitoring tools (such as Spotfire, Tableau, R-shiny)
- Demonstrated ability to operate and lead in a dynamic organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise.
- Extensive experience working with external vendors, including but not limited to acquisition, contracting, evaluation of vendor’s capabilities and deliverables
- Extensive knowledge of statistical software (SAS, R, EAST, etc.) and general computing techniques in addition to knowledge of R or other statistical software packages
- Able to organize multiple work assignments and establish priorities
- Excellent verbal and written communications skills; able to communicate proactively and effectively
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