Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Associate Director, Biostatistics. The position will report to the VP, Biostatistics and is located in Brisbane, CA.
This position will be responsible for providing guidance on clinical development plans, protocols and analysis, review clinical study reports and regulatory submission materials, and ensure that standard procedures are followed within projects. The individual will also interact with the head of statistical programming and data management to synchronize prioritization of projects and, in some cases, represent Biostatistics in meetings with executive committee, commercial, regulatory agencies, and external development partners in the absence of the Head of Biostatistics. This position reports to VP of Biostatistics.
Essential Duties & Responsibilities
- Provide statistical expertise to study designs and clinical development strategy as a Subject Matter Expert and point of reference in Biostatistics to ensure scientific integrity of the statistical methodology applied to clinical trials.
• Develop and review statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.
• Implement consistent statistical conduct for the department and liaise with clinical research personnel in order to identify and meet their needs for statistical support.
• Provide input to development programs including filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements.
• Utilize knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, and simulation techniques.
• Present and discuss statistical considerations as the representative of the Biostatistics function at Protocol Review Meetings.
• Prepare statistical analysis plans for integrated summary of safety (ISS) and integrated summary of efficacy (ISE) and statistical summary reports as appropriate.
• Write and/or review regulatory documents (e.g., ISS, ISE, regulatory Briefing books)
• Contribute to the planning and preparation for discussions on statistical methodology and/or analyses and their use/interpretation at Health Authority Meetings.
• Collaborate with other functional areas within the company (Clinical Data Management, Clinical Research, Global Drug Safety, Regulatory and Project Management).
• Research and apply new statistical procedures as needed.
• Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program (such as women’s health).
• Other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
- Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make decision that is appropriate for the organization
- Results-driven, take initiative and ownership to accomplish work
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
- Experience with analysis and reporting of phase 3 study data, as well as integrated summary of efficacy and safety (ISE and ISS).
- Experience with group-sequential designs and/or support of independent data monitoring committee for registration trials.
- Experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions desired.
- Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used.
- Ph.D. or M.S. in Biostatistics or Statistics, or equivalent related work experience.
- Ph.D. and 6+ years of experience in Biostatistics; M.S. and 8+ years of experience in Biostatistics with extensive experience within the Pharmaceutical and/or Biotechnology industries.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Travel is expected to support face to face interactions with regulatory authorities and select interactions with advisory boards and key opinion leaders on needed basis for assigned indication(s).
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
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Equal Employment Opportunity