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 redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission.Summary Description
The Senior Biostatistician is responsible for statistical aspects of assigned studies and provides support in study design, statistical analysis, and reporting of data. Plans, performs, coordinates, and reviews biostatistics deliverables for assigned studies. Provides input to planning of cross-functional activities to ensure timeliness and quality of study deliverables. This position reports to Associate Director, Biostatistics.
Essential Duties and Responsibilities
- Provide statistical expertise to study designs as a Subject Matter Expert in Biostatistics
- Responsible for production of the following study-related deliverables: appropriate sections of study protocols, case report forms, sample size estimation, patient randomization system, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and other registration documents (e.g. summary of safety and efficacy documents).
- 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.
- Responsible for the accuracy, completeness and interpretation of statistical analyses conducted for assigned studies. Maintains consistent analytical approaches and reporting formats within and across studies.
- Write and/or review the following study-related documents: appropriate sections of study protocols, data presentations, manuscripts, and sections of clinical study reports and other registration documents (ie summary of safety and efficacy documents).
- Research and apply new statistical procedures as needed.
- Prepare statistical summary reports.
- Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.
- Participate in study management team meetings, including investigators’ meeting.
- Other duties as assigned
- 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
- Substantial knowledge of statistical methodology, clinical experimental design and analysis for clinical trials.
- Possess good understanding of Biostatistics and Statistical Programming functional areas
- Proficient in SAS and an understanding of clinical data processing.
- Knowledge of other statistical and computational software packages (R, EAST, nQuery) is required
- Knowledge of CDISC requirements for SDTM and ADaM
- Knowledge of FDA and ICH requirements as they pertain to the analysis, presentation, reporting and monitoring of data is a plus
REQUIREMENTS (Education and Experience)
- Ph.D. or M.S. in Biostatistics or Statistics, or equivalent related work experience.
- Ph.D. and 3+ years of experience in Biostatistics; M.S. and 6+ years of experience in Biostatistics with extensive experience within the Pharmaceutical and/or Biotechnology industries.
- Experience with analysis and reporting of phase 2/3 study data. Experience with integrated summary of efficacy and safety (ISE and ISS) is a plus
- Experience with group-sequential designs and support of independent data monitoring committee for registration trials
- Experience with Patient Reported Outcome instruments and endpoints
- Experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions is a plus
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