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Associate Director, Biostatistics

Location
Watertown, Massachusetts
Job Type
Permanent
Posted
1 Oct 2021
Job Summary:

Our statisticians lead, develop and implement statistical solutions to support all phases of clinical trials and influence decisions across platforms. The successful candidate will function as an independent program statistician across multiple clinical development programs, and will supervise study level statisticians/programmers at CROs.

Enanta Statisticians are accountable for all biostatistics study deliverables and manage key trial responsibilities including: statistical design of all phases of trials, authoring of SAPs, and conducting just-in-time analyses and data exploration. The successful candidate must possess the desire and ability to work with study teams up through and including leadership responsibilities as part of our growing, evolving group.

Primary Responsibilities:

* Serve as the statistical leader and project manager for all biostatistics deliverables across assigned clinical development programs
* Manage outsourced biostatisticians/programmers, and mentor team members as needed
* Perform trial statistician responsibilities including attendance of study team meetings, authoring SAPs, reviewing CRFs, review of protocols/amendments, conducting exploratory data analyses, and performing just-in-time analyses
* Serve as a general clinical development and statistical resource at Enanta; participate in non-clinical project activities
* Help establish and maintain Enanta data standards, within and across programs (e.g. standardization of CRFs, outputs, SAPs)
* Plan and track study level activities within programs, including resources; ensure CRO timelines and objectives are met
* Ensure that clinical development programs (or parts assigned) meet scientific, regulatory, and quality requirements

Qualifications:

* PhD in Biostatistics and 3-6 years biopharmaceutical industry experience as a biostatistician OR
* Masters Degree in relevant statistics field and 5-8 years biopharmaceutical industry experience as a biostatistician
* Fluent in English (oral and written)
* Proven knowledge and expertise in statistics and its applications to clinical trials
* Proven ability to work independently
* Team player, with ability to work successfully across functions

General Qualifications:

* Collaboration & Teamwork: Relates to employees and management in a cooperative manner that helps others to achieve their best.
* Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
* Communication Skills: The ability to convey both written and verbal information effectively and efficiently.
* Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
* Detail-Oriented: Follows precise procedures and demonstrates thoroughness in performing job tasks and assignments.
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Details

  • Job Reference: 386581112-2
  • Date Posted: 1 October 2021
  • Recruiter: Enanta Pharmaceuticals, Inc.
  • Location: Watertown, Massachusetts
  • Salary: On Application
  • Sector: Science & Technology
  • Job Type: Permanent