Job Description
The Associate Director, Real World Statistics will overview and perform sophisticated scientific statistical analyses in support of the company's post-marketing areas for Global Medicines Development and Affairs (GMDA) and Commercial and Strategic Management (CSM), on new and complex issues with minimal guidance and mentoring. The Incumbent will serve a lead role on assigned projects including clinical trials, real world observational studies, market access and reimbursement activities, and other ad hoc analyses.
This is a hybrid position which allows for 2 days per week remote work, and 3 days per week in the Boston Seaport office. Relocation assistance is available.
Key Duties and Responsibilities:
- Responsible for all scientific and operational statistical work for multiple clinical trials and observational studies, or real world data (RWD) investigations.
- May include management, oversight, and strategic directions of one or more projects or major components of a project.
- Mentors junior personnel, possibly including one or more direct reports.
- May include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
- Possesses an advanced and in-depth understanding of modern drug discovery, development, and post-marketing processes.
- Represents Real World Statistics as a member of cross functional teams, providing strategic input and expert technical guidance to team members. Effectively collaborate with multiple stakeholders from Clinical Development, Medical Affairs, Health Economics and Outcome Research (HEOR), and Real World Evidence (RWE) teams.
- Develops technical leadership and guides project teams to more meaningful and/or productive ends.
- Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops study documents such as Cross-functional Data Review plan, Key Results Memo, and Data Dissemination Plan in order to facilitate the review, summary, and dissemination of key study data/results.
- Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality.
- Contributes to clinical study reports (CSRs) and related processes, authoring or co-authoring methodological or study-related publications and posters.
- Contributes to external interactions with regulators, payers, review boards, etc.
- Authors or co-authors methodological or study-related publications and posters.
- Contributes to departmental working group efforts on various advanced technical and operational issues.
Knowledge and Skills:
- Competence with SAS and R statistical software
- Demonstrated understanding of advanced statistical methods used in drug development
- Ability to show critical thinking with logical problem-solving
- Excellent written and verbal communication skills
- Excels in a team environment
- Collaborates well with non-statisticians
Education and Experience:
- Ph.D. in Biostatistics or related fields and 7 years of relevant work experience, or
- M.S. in Biostatistics and 10 years of relevant work experience
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