Associate Director, Biostatistics

Job-:
Research and Development

Location:

Waltham, MA, United States

Schedule:

Full time, First Posted:
This unique position offers an ambitious candidate the opportunity to contribute and learn through direct exposure to a wide spectrum of biometrics activities in support of Clinical Development, Regulatory Agency submissions and Medical Affairs activities.  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.

Qualifications Basic Requirements:

At least 4 years of experience in pharmaceutical, biotech, and/or CRO setting

Ph.D. in Biostatistics, Statistics or Applied Mathematics Preferred Requirements:.Ability to understand and develop statistical and patient-based models, using the latest tools and methodologies

Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data Strong statistical experience in clinical research and drug development

Experience in US and/or Non-US submissions

Strong communication and interpersonal skills; ability to interact with cross-functional teams

Travel Expectations:

Overnight travel ~10%
The annual base salary for this position ranges from $200,000 to $213,000. 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: #LI-HB1

Responsibilities The incumbent will be responsible for planning and executing a range of biostatistical activities to support design and analyses of clinical studies and their related medical affairs tasks. These responsibilities may also include ad hoc analyses of existing databases, study design simulation, meta-analyses, and data mining. Tasks include planning, programming, and executing statistical analyses; contributing to content and review of clinical study protocols, statistical analysis plans, clinical study reports, presentations and manuscripts;

and occasional instructing and reviewing third party statistical planning and analysis work.

Knowledge and Skills Needed:

Experience in the development of protocol, statistical analysis plans, programming, and analyses of Phase I-IV clinical trials

In-depth experience of R, Base SAS,SAS/STAT, and SAS/GRAPHExcellent analytical, problem solving and organization skills with the ability to work simultaneously in multiple tasks

Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks

Ability to work in a collaborative environment, desire to learn and improve skills

Ability to communicate statistical information to non-scientists, willingness to educate internal teams

Experience with standard statistical methods including but not limited to parametric and non-parametric analysis, survival analyses, longitudinal data analysis, logistic regression, methods used in handling missing data, MMRM, GEE, multiple testing procedures, multivariate statistics, meta-analysis and categorical data analysis

Ability to apply innovative statistical approaches to the design of studies (e.g., modeling and simulations, adaptive design and/or Bayesian approaches) Ability to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses.

Experience in managing statistical and programming activities of CROs  Experience in planning and preparation of integrated summary documents- ISE, ISSAbout the company

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various…