General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for ensuring the robust application of traditional and emerging statistical methodologies to support the development and execution of clinical development strategies that deliver medically-differentiated therapies that provide meaningful improvement to patients. Biostatistics personnel work closely with the Regulatory Affairs, Medical Science, Clinical Operations Development, Medical Affairs, and Translational Science functions to ensure that Sage’s development programs and their component clinical studies have high quality statistical analysis plans that satisfy desired messaging and study objectives, and that the analyses are completed on time and with high quality. Biostatistics personnel participate in the development of the Clinical Development (CD) strategy and plan and support the assigned Program Physician(s) with various deliverables necessary for effective and efficient CD plan execution. Responsible Biostatistics personnel have a primary responsibility of supporting Program Leaders and Program Physicians with the development of the statistical content of clinical documentation, representing biostatistics on various sub-teams or other appropriate forums, acting as a primary point of contact for questions and inquiries to biostatistics regarding CD studies or other programs, conducting ongoing data reviews, and providing biostatistics inputs into study data reporting, including medical publications.
Roles and Responsibilities
The Consultant Senior Biostatistics Lead is expected to execute many of his/her responsibilities independently and to have external interactions with regulatory authorities, cooperative groups, external experts, and vendors in support of CD work progress. The successful candidate will:
Participate in a number of new drug development programs as subject matter expert and and provide strategic and technical leadership in the design and execution of clinical development plans, clinical trials, and statistical analysis plans.
Serve as Biostatistics Program Lead for assigned compound(s) and/or study biostatistician.
Manage and oversee biostatisticians working on studies within his/her assigned compound(s) to insure timely and high-quality biostatistics deliverables.
Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines.
Be responsible for planning and developing budget and managing resources and expenses accordingly.
Work with the Clinical Development group to provide input to study design and the statistical section of clinical trial protocols.
Oversee production of, contribute to, or prepare statistical sections of protocols and statistical analysis plans.
Participate in planning for FDA/EMA meetings and preparation of associated responses.
Generate and/or verify sample size calculations and randomization schemes as needed.
Perform quality control checks of statistical analyses and SAS programs as needed.
Provide guidance to Biostatisticians and Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming.
Provide input to database requirements and work closely with the Clinical Data Manager to ensure data quality standards are met.
Work as part of a collaborative, cross-functional team with members from other disciplines.
Be responsible for vendor management for statistical, programming, and database functions.
Participate in other activities and meetings to support Biostatistics and the Development team as necessary.
Experience, Education and Specialized Knowledge and Skills
Master’s degree with at least 5 years of directly related experience.
Experience working on all phases of clinical trials (Phase 3 international clinical trials is a plus).
Experience working on NDA/BLA/MAA development and submissions, including hands-on experience working on ISS/ISE.
SAS programming expertise.
Understanding of ICH GCP as well as knowledge of industry practices and standards.
Written and oral communication and presentation skills.
Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, and Project).
Experience working on trials in CNS therapeutic area (Neuropsychological cognition testing in particular) is a plus but not a must-have.
Familiarity with CDISC/SDTM/ADaM data standard specifications.
Adaptive and Bayesian design experience is a plus.
People, projects, and vendor management experience is a plus.
Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
Excitement about the vision and mission of Sage.
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.