Associate Director, Biostatistics HEOR

General Scope and Summary

The Biostatistics group within Sage Therapeutics Data Science 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, Health Economics and Outcome Research (HEOR), and Translational Medicine/Science functions to ensure that Sages 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), HEOR, and Real-World evidence strategies and execution of some relevant tactical plans, as well as support the assigned Program Leaders(s) with various deliverables necessary for effective and efficient plan execution. Biostatistics personnel have primary responsibilities of 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

• Execute many responsibilities independently and seamlessly interact with internal and external collaborators in support of HEOR work progress.

• Provide statistical expertise in the design, execution, and analysis of HEOR studies, including observational studies, randomized controlled trials, and real-world data studies.

• Contribute with HEOR and Medical Affairs teams to develop clinical and economic value evidence generation strategy and publication plan.

• Review and interpret study results and contribute to the preparation of study reports, value/reimbursement dossiers, and publications/abstracts.

• Serve as Biostatistics lead for one or more studies.

• Monitor assigned work progress to insure successful deliverables against goals and timelines.

• Work with cross-functional team to provide input to study design and the statistical section of clinical trial protocols.

• Apply innovative statistical approaches and data exploration techniques to gain insights and uncover hidden values.

• Oversee production of, contribute to, or prepare statistical sections of protocols and statistical analysis plans.

• Perform quality control checks of statistical analyses and programs as needed.

• Work as part of a collaborative cross-functional team with members from other disciplines.

• Manage vendor relationships and oversee statistical, programming, and data management activities.

• Participate in other activities and meetings to support Biostatistics and the Development team as necessary.

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 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.

Basic Qualifications

• PhD in statistics, biostatistics, or applied mathematics with 6+ years of experience in clinical trials; or MS in statistics, biostatistics, or applied mathematics with 10+ years of experience in clinical trials.

Preferred Qualifications

• PhD in statistics, biostatistics, or related field with 8+ years of experience, including late-stage clinical trials; or MS in statistics, biostatistics, or related field with 12 years of experience, including late-stage clinical trials (phase3b/4).

• 3+ years of experience working in support of HEOR or real-world evidence generation activities.

• Experience working on development of HTA and reimbursement submissions, as well as commercialization activities.

• Solid knowledge of health economic concepts, such as cost-effectiveness analysis and decision modeling.

• Experience with analysis of patient reported outcomes and quality of life survey data.

• Familiarity with advanced statistical methods used for analysis of real-world data, such as observational studies.

• Proficiency in statistical programming languages (e.g., SAS, R, Stan, JAGS, and Python).

• 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.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.

• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Companys annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.