Associate Director, Biostatistics - Medical Affairs
Brisbane, CA, USA | Myovant Sciences Ltd.
Industry:Pharmaceutical / Biotech
Job Description:71 people have viewed this job
The Associate Director, Biostatistics - Medical Affairs will provide statistical support to indication(s)/product(s) primarily within Medical Affairs. He/she will be the statistical lead responsible for all statistical aspects and deliverables for product(s)/project(s) in regards to Medical Affairs activities. Together with Medical Affairs and HEOR colleagues, he/she will define future research questions, plan and execute statistical analysis, provide input into Medical Affairs lifecycle management strategy and tactics, provide input into and align with the publications plan, and support HEOR studies intended for payer and reimbursement needs. He/she will need strong communication skills to interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical colleagues. Working in a dynamic team with a wide range of interfaces, the role requires both strategic and operational skills combining innovative statistical thinking with a strong sense of business acumen. The Associate Director will be responsible for implementing consistent statistical conduct for the department and liaising with clinical research and medical affairs personnel in order to identify and meet their needs for statistical support. The Associate Director 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.
Essential Duties and Responsibilities
Statistical Expertise in Study Design and Analysis
Provides expert scientific/statistical input into research study design, formulates novel methods to problem solving, and independently develop the statistical analysis plan to implement those solutions.
Expertise in statistical methods to support Medical Affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials).
Expertise in statistical methods to support Health Economics and Outcomes Research including potential meta-analysis (including Bayesian network meta-analysis), patient reported outcomes (including development/validation), studies using external databases (e.g., claims, EMR, etc.), HTA/reimbursement/value dossiers, and real world evidence data/studies.
Expertise in statistical methods to support new studies (e.g., Phase IIIb/IV) including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, pragmatic clinical trials, etc.
Researches and applies new statistical procedures as needed.
Maintain up-to-date with state-of-the-art statistical science by participating in scientific societies, constant review of the clinical and statistical literature, and translate and apply relevant innovative statistical methodology to everyday work.
Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program (such as women’s health, oncology).
Plan and Execute Statistical Analysis
Author the Statistical Analysis Plan (SAP) to define the appropriate statistical analyses to address research questions, specifications for data derivation, specifications for the statistical analysis methodology, and the display shells for the outputs to be generated in collaboration with key stakeholders.
Perform and/or oversee statistical analyses using SAS to generate tables, listings, and figures for use in publications/presentations and for internal purposes.
Ensures quality of deliverables through appropriate testing and active review for completeness and accuracy including oversight of work packages outsourced to CROs (including developing and implementing an oversight plan).
Interpret results and communicate conclusions.
Collaborates with other functional areas within the company (Clinical Data Management, Clinical Research, Global Drug Safety, Regulatory, Medical Affairs and Project Management).
Ensures that study/project-related biostatistics and programming work is carried out in a timely and compliant manner.
Medical Analytics Departmental Initiatives
Develop standards within Medical Analytics including statistical position papers, standard analysis/display catalogues, and SAS macro libraries.
Further the technology, systems, and process infrastructure within Medical Analytics.
Educate and disseminate knowledge throughout the organization for areas within the expertise of Medical Analytics.
Other duties as assigned.
Core Competencies, Knowledge, and Skill Requirements
PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Solid knowledge of statistical methodology, clinical experimental design and analysis for clinical trials. Women’s health or Oncology therapeutic area expertise is a plus.
Requires proficiency in SAS and an understanding of clinical data processing.
Knowledge of FDA and ICH regulations/requirements as they pertain to the analysis, presentation/reporting, and monitoring of data.
Understands roles of Biostatistics, Statistical Programming and Data Management and provides adequate statistical expertise within a cross-functional team in clinical development.
Excellent verbal and written communication skills.
Ability to effectively collaborate in a dynamic environment.
Ph.D. or M.S. in Biostatistics or Statistics, or equivalent related work experience.
Ph.D. and 6-8+ years of experience in Biostatistics; M.S. and 8-10+ years of experience in Biostatistics with extensive experience within the Pharmaceutical and/or Biotechnology industries.
Experience in statistical support to Medical Affairs (including publication, Health Economics and Outcomes Research), patient reported outcomes (including development/validation), studies using external databases (e.g., claims, EMR, etc.), HTA/reimbursement/value dossiers, and real-world studies.
Experience in late stage of clinical development such as analysis and reporting of phase 3 study data.
Experience in using meta-analysis (including Bayesian network meta-analysis), or with group-sequential designs and/or support of independent data monitoring committee for registration trials.
Experience with statistical methodology and analysis for clinical trials in endocrinology or oncology.
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.
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