Director of Data and Biostatistics (Only W2, No C2C)

Acton, MA, US • Posted 30+ days ago • Updated 18 hours ago

Contract W2

On-site

$130 - $145/hr

Fitment

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Job Details

Skills

Biostatistics
Clinical Research
Clinical Trials
Data Collection
Data Integration
Data Integrity
Data Management
Data Quality
Database Design
Health Informatics
Life Sciences
Medical Devices
Project Management
Regulatory Compliance
Regulatory Affairs
Statistics
Research
Leadership
medical device
Oracle InForm
REDCap
CDISC
SOPs
Director of Data and Biostatistics
lead data operations

Summary

Job Title: Director of Data and Biostatistics (Only W2, No C2C)
Job Location: Acton, MA (Hybrid)

Job ID: 407
Job Location: 12 Months

Must be local to Acton, MA and available for onsite meetings
Description:
The Director of Data and Biostatistics will lead data operations for our Clinical Affairs team focused on medical devices. This role will be responsible for overseeing the design, implementation, and maintenance of clinical data systems, ensuring data integrity, and supporting regulatory compliance across all clinical studies. In addition, this role will be responsible for overseeing the statistical analysis of clinical study data ensuring appropriate statistical methods and accurate analyses to evaluate efficacy and safety and answer research related questions.
Responsibilities:

Lead the development and execution of data management strategies for clinical trials involving medical devices.
Support the design of clinical studies and ensure accurate interpretation of clinical study data working cross functionally to ensure the needs of the business are met.
Lead the development and execution of statistical analysis plans for clinical studies.
Oversee the design and validation of clinical databases (e.g., EDC systems) and ensure alignment with study protocols and regulatory requirements.
Collaborate with cross-functional teams including Clinical Operations, Medical Affairs, Regulatory Affairs, and Quality Assurance.
Ensure high-quality data collection, cleaning, and reporting processes.
Manage data management and biostatistics vendors and CROs, ensuring deliverables are met on time and within budget.
Develop and maintain SOPs and best practices for biostatistics and data management activities.
Provide leadership and mentorship to data management and biostatistics staff. This role will have direct reports.
Performs other duties as required.

Education and Experience:

Master's degree in Life Sciences, Health Informatics, Biostatistics or related field.
Minimum of 8 10 years of data management and/or biostatistics experience in clinical research, with at least 3 years in a leadership role.
Strong background in medical device clinical trials and understanding of FDA and ISO regulations (e.g., 21 CFR Part 11, ISO 14155).
Knowledgeable in statistical methods.
Proficiency with clinical data systems (e.g., Medidata Rave, Oracle InForm, REDCap).
Experience with device data integration and analysis.
Solid understanding of database design, data standards (e.g., CDISC), and data quality assurance
Excellent communication, leadership, and project management skills.

Skills/Competencies:

Excellent written and effective verbal communication skills.
Ability to communicate cross-functionally across the organization.
PC skills; word processing, spreadsheet, database, Internet search and utilization.
Flexible and able to work in a fast-paced environment.
Team player.
Ability to organize and judge priorities.
Excellent ability to generate and maintain accurate records.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 90941473
Position Id: 407
Posted 30+ days ago

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Director of Data and Biostatistics (Only W2, No C2C)

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Job Details

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