Associate Director, Biostatistics

Alkermes

9d•Hybrid

About The Position

This position supports Clinical Development, regulatory agency submissions, and Medical Affairs activities through a broad range of biometrics work. The role operates under a hybrid workplace model, with 60% of time in the office and 40% from home, and requires onsite work at the Waltham, Massachusetts office at least three days per week. It is not eligible for fully remote work. The incumbent plans and executes biostatistical activities supporting the design and analysis of clinical studies and related Medical Affairs work. Activities may also include ad hoc analyses of existing databases, study-design simulations, meta-analyses, and data mining. The role includes 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 and reviewing third-party statistical planning and analysis work. The annual base salary range is $200,000–$213,000, and the position is eligible for an annual performance-pay bonus. Compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package, with further details on its careers website. Overnight travel is approximately 10%.

Requirements

Ph.D. in Biostatistics, Statistics, or Applied Mathematics.
At least 4 years of experience in a pharmaceutical, biotech, and/or CRO setting.
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 analysis, survival analyses, longitudinal data analysis, logistic regression, methods for handling missing data, 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.
Ability to guide data management and programming in developing database standards, edit checks, and statistical programming for data analyses.
Experience managing statistical and programming activities of CROs.
Experience planning and preparing integrated summary documents, including ISE and ISS.
Excellent analytical, problem-solving, and organizational skills, including the ability to manage multiple tasks simultaneously.
Flexibility when priorities change; attention to detail; ability to work under pressure and take on unfamiliar tasks.
Ability to work collaboratively and interest in learning and improving skills.
Ability to communicate statistical information to non-scientists and willingness to educate internal teams.
Overnight travel of approximately 10%.

Nice To Haves

Ability to understand and develop statistical and patient-based models using the latest 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 US and/or non-US submissions.
Strong communication and interpersonal skills, including the ability to interact with cross-functional teams.

Responsibilities

Plan and execute biostatistical activities supporting clinical-study design and analysis and related Medical Affairs tasks.
Conduct, as needed, ad hoc analyses of existing databases, study-design simulations, meta-analyses, and data mining.
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.
Apply statistical approaches to clinical-study design, including modeling and simulations, adaptive design, and/or Bayesian approaches.
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.
Communicate statistical information to non-scientists and educate internal teams.