Sr Dir, Biostatistics

Alkermes

17h•Hybrid

About The Position

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.

Requirements

Ph.D. in Statistics or Biostatistics
16+ years of clinical research and drug development experience
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

Nice To Haves

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

Responsibilities

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