Associate Director, Biostatistics

Alkermes; United States; Hybrid; USD 200.000 - 213.000; Vollzeit

Zusammenfassung

Alkermes, headquartered in the United States, offers a hybrid work environment with 60% time in the office and 40% from home. The role is onsite at our Waltham, MA office at least 3 days per week and is not eligible for full remote work.

The incumbent will plan and execute biostatistical activities to support design and analyses of clinical studies and medical affairs tasks, including SAS/R analyses, protocols, SAPs, CSRs and manuscripts. Travel ~10% is expected.

Qualifikationen

• PhD in Biostatistics, Statistics or Applied Mathematics is required.
• At least 4 years of pharma/biotech/CRO experience.
• Experience with designing and analyzing Phase I-IV trials and regulatory submissions.

Aufgaben

• Plan and execute biostatistical analyses for clinical studies and medical affairs.
• Contribute to study protocols, SAPs, CSRs, and manuscripts.
• Possibly supervise CRO statistical planning and analyses and provide training.

Kenntnisse

Biostatistics leadership

R

SAS

SAS/STAT

SAS/GRAPH

Data analysis

Clinical trial statistics

Communication to non-scientists

CRO management

Study design and analysis

Ausbildung

PhD in Biostatistics

Statistics

Applied Mathematics

Tools

R

Base SAS

SAS/STAT

SAS/GRAPH

Jobbeschreibung

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.

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

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: www.alkermes.com/careers#working-here

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