Associate Director, Biostatistics at Biogen in Cambridge, MA

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Summary
The Associate Director, Biostatistics is responsible for providing the statistical expertise for products within a therapeutic area, including response to statistical issues arising in regulatory, commercial, worldwide medical or other legal settings, and may include addressing issues from external development partners and internal cross-functional project teams.
Job Description
The Associate Director, Biostatistics is responsible for providing the statistical expertise for products within a therapeutic area, including response to statistical issues arising in regulatory, commercial, worldwide medical or other legal settings, and may include addressing issues from external development partners and internal cross-functional project teams. He/She builds and maintains strong collaboration with collaborators from different disciplines across the organization to identify and meet their needs for statistical support. He/She also contributes to the long-term growth strategy of the department. This person provides mentorship to junior biostatisticians in the department. He/She ensures that standard procedures are followed within projects. This person will act as CDT statistician and will have limited participation in Asset Team Meetings. May act as SMT statistician for complex Phase 3 studies. Will also have increased exposure to KOL collaborations/meetings.

Successful candidate will:
* Represent Biostatistics on CDT/Asset teams and provides professional statistical support to clinical development team. Ensure timeliness and high quality of Biostatistics deliverables. Able to handle requests from regulatory agencies, health authorities, across multiple drug programs, often under tight timelines.
* Able to make decisions at CDT level across a variety of studies with minimal input from line or project manager. Able to work with others to identify and resolve areas of concerns. Takes initiative to communicate issues within or across multiple project team(s). Able to handle large volume of highly complex tasks with minimal supervision.
* Will be the primary contact for management, CDT/Asset teams, CROs, KOL's in respect to statistical consultation for products within a TA. Interacts with team members across functional areas and multiple studies. Represents the organization in meetings or on teams.
* Lead organization-wide led initiatives e.g. Quality, standardization etc.
Qualifications
* Broad and thorough understanding of statistical principles and clinical trial methodology, and the ability to practice and implement them.
* Ability to develop innovative/creative statistical/technical solutions to complex problems.
* Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
* Broad knowledge of medical/biological terminology and clinical trial designs and competitive landscape in relevant therapeutic areas.
* Attentive to detail.
* Able to write and present information effectively.
* Conversant with SAS programming, and detailed knowledge of SAS procedures and other statistical software.
* Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
* Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc.
Education
PhD in Biostatistics/Statistics or equivalent with a minimum of 8 years relevant work experience is ideal. Would consider MS in Biostatistics/Statistics with a minimum of 10 years relevant experience.
All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.
As an employer of choice, we strive to:
Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organization
Pursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutions
Comply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employment
VEVRAA Federal Contractor
We Request Priority Protected Veteran and Disabled Referrals for all of our locations

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