Vice President, Biostatistics & Statistical Programming
General Scope and Summary
The Data Science department within the Sage Development organization is responsible for ensuring the application of both traditional and emerging statistical methods, modeling and simulation techniques, data acquisition, and protocol and clinical study report writing that support the development and execution of clinical development strategies. The Vice President, Biostatistics & Statistical Programming will play a critical role in developing Sage’s strategies for clinical trial designs, data gathering, analysis, interpretation, presentation, and reporting. This position is responsible for building strategic Biostatistics & Statistical and Data Programming groups.
The Vice President, Biostatistics & Statistical Programming will play an active, strategic role in supporting company ongoing and upcoming pre-clinical and clinical research and will interface extensively with Clinical Development and Discovery teams to effectively integrate drug development process across all R&D functions.
Roles and Responsibilities
This position requires deep statistical and operational expertise, a proven ability to build and manage fully capable Data Science-related functions, and a proven ability to thrive in several critical areas, including but not limited to: a track record of proven leadership and expertise in trial design, data gathering, analysis, interpretation/reporting, and presentation.
Contribute to the strategic planning of Sage’s Clinical Development programs.
Lead Biostatistics & Statistical and Data Programming groups.
Work closely with other Clinical Development leaders in the organization to develop the optimal strategies to grow the portfolio and advance development programs.
Contribute to the development of innovative clinical trial designs.
Develop innovative analytic strategies for clinical trial data collection, analysis, and presentation.
Communicate and resolve all statistical-related issues with FDA and other health regulatory authorities.
Collaborate with Data Standards, Data Management, and Medical Writing to effectively execute and oversee all Data Science-related activities, timelines, and deliverables for in-house as well as outsourced services, including data capture, quality control, medical coding, data mapping for statistical analyses, and other activities from study startup through data lock.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent communication and interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
PhD or Master’s degree in statistics or mathematics.
15+ years (20+ years for MS) in clinical and drug development in the pharmaceutical/biotech industry, including regulatory submission/approval experience.
8+ years of people management experience.
Excellent understanding of drug development from pre-IND through NDA/MAA.
Track record of technical experience in development of GCP-related processes and procedures in support of biostatistics and statistical programming activities; management of CROs, multiple vendors, and complex protocols.
Track record of impactful scientific and technical presence in industry.
Proven record of previous proactive and productive participation at meetings with FDA and other regulatory agencies (e.g., end of Phase 2, Pre-NDA, Advisory Committee, Scientific Advice with EMA, PMDA).
Advanced knowledge of statistical and predictive analysis methods in clinical development, including Bayesian and adaptive/flexible design approaches, missing data and multiplicity issues, and strong working knowledge of statistical software and data visualization packages such as SAS and EaSt.
Experience in CNS/neurology and experience with orphan indications preferred.
Understanding of the scope and focus of clinical trials phase 1-4 and a proven ability to perform the tasks as well as manage vendor resources and timelines.
In-depth understanding of regulatory guidelines e.g., ICH, GCDMP, 21 CFR Part 11 and their application to data management, programming, and statistics practice. Knowledge of and experience with MedDRA and WHODrug data dictionaries. Working knowledge of CDISC standards.
Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
Strong team player that has a customer service approach and is solution-oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Strong written and verbal communication skills.
Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, Forge New Pathways.
Excitement about the vision and mission of Sage.
Proven negotiation skills.
All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.