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Director, Biostatistician

Employer
Sage Therapeutics
Location
Working from Home
Start date
Jan 26, 2024

View more

Discipline
Science/R&D, Biostatistics
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details

General Scope and Summary

The Biostatistics group within 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 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) 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 primary responsibilities 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 Director, Biostatistics is expected to execute many of their 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 for this position will:

  • Demonstrate strong strategic, statistical, and clinical skills and apply appropriate the strategies and techniques in a wide variety of situations, especially those required for the design, conduct, and analysis of clinical trials.

  • Be familiar with current innovative trial design and analysis methods.

  • Effectively communicate statistical concepts to non-statistical audiences (e.g., Medical Science, Clinical, Regulatory Affairs, and Medical Affairs colleagues).

  • Exhibit an understanding of the regulatory environment for development of drugs and biologics in the United States, Europe, and other jurisdictions; author responses and other documents for regulatory agencies and contribute to preparation and execution of meetings with regulators.

  • Assist in clinical trial design, including issues related to blinding and bias minimization

  • Be familiar with SAS software and additional statistical packages as needed.

  • Work in and resolve conflict in cross-functional teams.

  • Exhibit an understanding of drug development issues common to other functions (e.g., Clinical Operations, Regulatory Affairs) and work to achieve solutions that balance the needs of both Biostatistics and other groups.

  • Author protocol statistical sections, SAPs, and results and methods sections of clinical study reports and manuscripts.

  • Provide strategic and technical input into clinical development plans.

  • Work independently.

  • Manage multiple projects/tasks, people, and appropriately prioritize such tasks.

  • Show a strategic interest in the competitive environment for products being developed.

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, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations.

Basic Qualifications

  • PhD with 8+ years of experience in clinical trials, or MS with 10+ years of experience in clinical trials.

Preferred Qualifications

  • PhD in statistics or biostatics with 12+ years of experience, or MS in statistics or biostatistics with 15+ years of experience preferred.

  • Must demonstrate familiarity with both early and late-stage drug development as well as statistical aspects of drug development regulations with regards to design and conduct of clinical trial, and analysis data therefrom.

  • Have experience interacting with drug development regulatory agencies (e.g., FDA and/or EMA).

  • Possess strong interpersonal, verbal, and written communication skills.

  • Excellent project management skills (including management of vendor/CRO outsourced work).

  • Able to prioritize multiple tasks and goals to ensure timely and within-budget high quality deliverables.

  • Work well within multi-disciplinary teams and have proven ability to coordinate and drive projects in a matrix organization.

  • 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, as well as Data Science mission.

Benefits and Compensation The base salary hiring range for this position is $181,497 - $249,558.*
  • 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.
*Base salary ranges are periodically reviewed and subject to change. #LI-Remote

Company

Welcome To The Workplace With A Difference

Our vision is to fearlessly lead the way to create a world with better brain health – a vision we can only achieve with the help of our amazing team of highly knowledgeable, deeply passionate individuals.

At Sage, we believe that life is more than just a destination. We’re concerned with the journey, and we care deeply about everyone contributing to and benefiting from our own company journey. This means helping people discover the right path for them and carefully guiding colleagues along the way.

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Stock Symbol:

SAGE

Company info
Website
Phone
617-299-8380
Location
215 First Street
Cambridge
MA
02142
United States

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