Director, Biostatistics

Location
Working from Home
Posted
Jan 20, 2022
Ref
R001024
Required Education
Masters Degree/MBA
Position Type
Full time

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 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 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

  • Participate in a number of new drug development programs as subject matter expert and provide technical leadership in the design and execution of clinical trials and statistical analysis plans.

  • Serve as the 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 the 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

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 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 NDA/BLA/MAA development and submissions.

  • Experience working on all phases of clinical trials.

Preferred Qualifications

  • Experience working on Phase 3 clinical trials.

  • Hands-on experience working on ISS/ISE.

  • 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, and 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.

Employment Type:Employee

Number of Openings:0

Job ID:R001024

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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.

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