General Scope and Summary
The Biostatistics group within the Sage Therapeutics 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. Biostatistics personnel have primary responsibilities for 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 points-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 Associate Director, Biostatistics is expected to execute many of his/her responsibilities semi-independently, and to interact with 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 provide technical leadership in the design, execution of clinical trials, and statistical analysis plans.
- Serve as biostatistics lead for one or more studies.
- Monitor assigned work progress to insure successful deliverables against goals and timelines
- Work with the Study Management Team 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 Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming.
- Provide input to database requirements and work closely with Clinical Data Manager to insure 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
- PhD in statistics, biostatistics, or related field, with at least 8 years of experience in clinical trials; or MS in statistics, biostatistics, or related field, with 12 years of experience in clinical trials.
- 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 is plus.
- Ability to manage people and projects.
- Must have vendor oversight experience.
- SAS programming expertise
- Understanding of ICH GCP as well as knowledge of industry practices and standards.
- Fluency in English, both oral and written.
- Written and oral communication and presentation skills.
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, Project).
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.