Senior Manager/Associate Director, Biostatistics will report directly to the Senior Director, Biostatistics. This role will be responsible for providing the statistical expertise to multiple Clinical Research and Development programs.
Plays a key role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents.
Conduct commonly used statistical analyses clinical trials.
Oversee definition and implementation of study/project level database (including derived database), analysis and reporting standards. Coordinate with Data Management and Programming to target high quality databases and specifications at project level.
Plan and direct study/project level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers.
Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
Anticipate and communicate resource and quality issues that may impact deliverables or timelines at project level. Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
Consider and evaluate alternative analysis methodology and data presentation techniques.
Collaborate with external investigators and vendors in the preparation of scientific presentations and manuscripts.
Collaborate with clinical research and development team to support publications, regulatory submissions, and other related activities.
Education and Experience:
PhD in statistics/biostatistics with minimum of 4 year of experience in pharma/biotech or MS in statistics/biostatistics with minimum 6 years of experience in pharma/biotech.
Strong statistical programming skills using SAS, R and other relevant software.
Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data presentation and interpretation practices.
Experience with clinical research.
Experience with NDAs, MAAs and other regulatory submissions a plus.
Ability to work effectively in a cross-functional environment.
Good communication and interpersonal skills.
Strong project management skills.
Good knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
Good knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
About Kiniksa Pharmaceuticals
Kiniksa is a publicly traded biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need.
We have a sequential pipeline consisting of five product candidates across various stages of development, focused on autoinflammatory and autoimmune conditions. We are relentless and focused on patients and strive to develop life-changing medicines.
We are focused on hiring and retaining a highly skilled team that has extensive experience and specific skill sets relating to the selection, development, and commercialization of transformative therapies. Whether in development, research, manufacturing, technical operations, or general / administrative functions, we depend on a brilliant team to support our mission of building a global, generational company.
Our benefits are competitive, and we offer dynamic career opportunities across our organization fostering a culture that embraces passion and rapid execution.
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