Associate Director, Biostatistics

Alkermes•Waltham, MA

5h•$200,000 - $213,000•Hybrid

About The Position

This role offers the opportunity to contribute to a broad range of biometrics activities supporting Clinical Development, regulatory agency submissions, and Medical Affairs. The position operates under Alkermes’ hybrid workplace model, with work performed onsite at the Waltham, Massachusetts office at least three days per week and the remaining time from home; fully remote work is not available. The incumbent plans and executes biostatistical activities supporting clinical study design and analysis, as well as related Medical Affairs work. Activities may also include ad hoc analyses of existing databases, study-design simulations, meta-analyses, and data mining. The role involves planning, programming, and executing statistical analyses; contributing to and reviewing clinical study protocols, statistical analysis plans, clinical study reports, presentations, and manuscripts; and occasionally instructing on or reviewing statistical planning and analysis work performed by third parties.

Requirements

At least 4 years of experience in a pharmaceutical, biotech, and/or CRO setting.
Ph.D. in Biostatistics, Statistics, or Applied Mathematics.
Experience developing protocols and statistical analysis plans, programming, and analyzing Phase I–IV clinical trials.
In-depth experience with R, Base SAS, SAS/STAT, and SAS/GRAPH.
Experience with standard statistical methods, including parametric and non-parametric analyses, survival analyses, longitudinal data analysis, logistic regression, missing-data methods, MMRM, GEE, multiple-testing procedures, multivariate statistics, meta-analysis, and categorical data analysis.
Ability to apply innovative statistical approaches to study design, such as modeling and simulations, adaptive design, and/or Bayesian approaches.
Excellent analytical, problem-solving, and organizational skills, including the ability to manage multiple tasks simultaneously.
Flexibility with changing priorities, attention to detail, ability to work under pressure, and readiness to take on unfamiliar tasks.
Ability to work collaboratively and willingness to learn and improve skills.
Ability to communicate statistical information to non-scientists and willingness to educate internal teams.
Experience managing statistical and programming activities of CROs.
Experience planning and preparing integrated summary documents, including ISE and ISS.

Nice To Haves

Ability to understand and develop statistical and patient-based models using current tools and methodologies.
Strong analytical skills and demonstrated experience gathering, interpreting, and analyzing data.
Strong statistical experience in clinical research and drug development.
Experience with U.S. and/or non-U.S. submissions.
Strong communication and interpersonal skills, including the ability to interact with cross-functional teams.

Responsibilities

Plan and execute biostatistical activities supporting the design and analysis of clinical studies and related Medical Affairs tasks.
Conduct ad hoc analyses of existing databases, study-design simulations, meta-analyses, and data mining as needed.
Plan, program, and execute statistical analyses.
Contribute to and review clinical study protocols, statistical analysis plans, clinical study reports, presentations, and manuscripts.
Occasionally instruct on and review third-party statistical planning and analysis work.
Guide data management and programming in developing database standards, edit checks, and statistical programming for data analyses.
Manage statistical and programming activities of CROs.
Plan and prepare integrated summary documents, including ISE and ISS.