Associate Director, Biostatistics
Alkermes
Summary
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.
Job description
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/GRAPH
- Excellent 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, ISS
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%
Requirements
- At least 4 years of experience in pharmaceutical, biotech, and/or CRO setting
- Ph.D. in Biostatistics, Statistics or Applied Mathematics
- 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/GRAPH
- Experience with standard statistical methods including 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, ISS
- Excellent analytical, problem solving and organization skills
- Ability to communicate statistical information to non-scientists
- Ability to work in a collaborative environment
Benefits
- Performance pay bonus
- Competitive benefits package
Company overview
Alkermes plc is a global biopharmaceutical company specializing in neuroscience-focused medicines for psychiatric and neurological disorders. Founded in 1987 and headquartered in Dublin, Ireland, the company maintains a significant research and development center in Waltham, Massachusetts, and a manufacturing facility in Wilmington, Ohio. Alkermes has established itself as a leader in developing treatments for complex conditions including schizophrenia, bipolar I disorder, alcohol dependence, and opioid dependence. The company's portfolio includes proprietary commercial products such as Lybalvi (olanzapine/samidorphan), Aristada (aripiprazole lauroxil), and Vivitrol (naltrexone), alongside a robust pipeline of clinical and preclinical candidates targeting neurological disorders like narcolepsy and idiopathic hypersomnia. With approximately 1,800-2,100 employees worldwide, Alkermes combines deep neuroscience expertise with sophisticated development capabilities to address traditionally overlooked or stigmatized conditions, maintaining a patient-centered approach to drug development and commercialization.