Senior Manager, Biostatistics
Job Req: CLD19-004
At Blueprint Medicines, we are creating a blueprint for the future of healthcare. We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease. We do this by leveraging our one-of-a-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally. This prolific scientific platform has enabled Blueprint Medicines to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.
This position is responsible for statistical aspects of study designs, planning and execution of statistical analyses for multiple clinical development programs, health authority submissions, presentations and publications, by working closely with colleagues in clinical development, translational medicine and research, and with key outsourced functions including data management, SAS programming, clinical pharmacology, medical writing, and regulatory affairs to advance Blueprint Medicine's drug candidates under development. This position will serve as the in-house statistical expert and provide statistical consultation to all functions within Blueprint as necessary.
Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of all sections.
Author statistical analysis plans for clinical trials, and author/edit mock tables, listings and figures.
Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses.
Specify randomization schedules and test their implementations.
Work with external statistical programmers and data managers to generate tables, listings and figures.
QC the key results of statistical programmers.
Support ongoing safety review of the program/study teams and data monitoring committees.
Perform ad hoc statistical analyses and basic SAS programming as needed.
Contribute to the clinical study reports, including authoring of statistical sections and interpretation of the study results.
Support regulatory submissions.
Support the preparation of publications, including manuscripts, posters and oral presentations.
Provide requirements and oversight to external statistical programmers, data managers and other relevant functions at CROs to ensure quality of deliverables.
Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
Provide statistical input on CDP, IDP, and registration plan.
Provide analysis support for presentations and publications.
Keep abreast of new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc.
Knowledge of statistical methods that apply to Phase I-IV clinical trials.
Knowledge of FDA and ICH regulations and guidelines.
Interaction with regulatory authorities desired.
Experience investigating the relationships between biomarkers and clinical endpoints is desirable but not required.
Relevant experience partnering with CROs.
Proficient in statistical programming (SAS is required, and R is a plus).
Experience with trial design software (e.g., EAST); working knowledge of Spotfire is desired.
Proven experience concurrently supporting multiple studies, providing timely and scientifically sound statistical expertise as well as exceptional attention and accuracy with the study details.
Strong interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills.
Self-motivation and self-confidence are critical.
All applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability or protected veteran status.
WHO WE ARE:
Blueprint Medicines' mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.
We don't think in small steps. We think in giant leaps.
We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.
We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.
Blueprint Medicines Corporation