Senior Director, Biostatistics
At a glance
Director-level Data Science role at Alkermes. Waltham · full-time · $274,820–$293,881 base.
dataroles summary, based on the employer's posting.
What you'll do
- Guide study design, statistical methods, result analysis and interpretation across Phase I, IV drug development
- Shape clinical development plans with senior partners across functions to support corporate objectives
- Oversee statistical strategy for regulatory discussions and help prepare briefing books and integrated summaries
- Coordinate statistical work with CROs, consultants and other outside groups, tracking vendor metrics and deliverables
- Advance trial methods and contribute to department procedures and clinical development practices
What you bring
- A Ph.D. in statistics or biostatistics is required
- At least sixteen years working in clinical research and drug development
- You bring substantial clinical-trial methodology knowledge, especially for registration and life-cycle management
- You have deep or recent neuroscience experience and have engaged with US and international regulatory agencies
Who this fits
This role suits a senior biostatistics leader who can advise on development strategy, explain statistical findings to non-scientists and work across functions. It requires at least three onsite days each week at the Waltham office; fully remote work is not available. Domestic and international travel may reach fifteen percent.
From the employer
In this position, the Senior Director, Biostatistics will work with a team of statisticians supporting drug development activities and decision-making encompassing Phase I-IV studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Proven experience in strategic input into clinical development plans, and familiarity with regulatory standards and requirements.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
Work with a team of high performing Clinical Biostatisticians with a clear vision in mind to meet corporate regulatory, scientific, and business objectives
Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
Design and analyze clinical studies using appropriate and innovative statistical methods
Provide oversight of statistical and strategic content in support of regulatory interactions
Effectively coordinate statistical endeavors with outside organizations, CROs and consultants
Identify and implement emerging new ways of doing clinical development and new methodologies
Participate in establishment and development of department SOPs
Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
Maintain an active role in planning and preparation of regulatory submissions- briefing books and integrated summary documents
Basic Requirements:
Ph.D. in Statistics or Biostatistics
16+ years of clinical research and drug development experience
Preferred Requirements:
Recent or in-depth experience working in the field of neuroscience
In-depth knowledge of methodologies applied in clinical trials with focus on registration and life cycle management
Extensive experience of interactions with regulatory agencies- US and Non-US
Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
Strong communication and interpersonal skills; ability to interact with cross-functional teams
Flexible to changing priorities, detail-oriented, works well under pressure
Ability to communicate statistical information to non-scientists, willingness to educate internal team
Travel Expectations:
Travel domestic and international- up to 15%
The annual base salary for this position ranges from $274,820 to $293,881. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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