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Apex Systems · 5 days ago

Director of Data and Biostatistics

Acton, MA

Full-time

Onsite

Director/Executive

$115/hr - $143/hr

8+ years exp

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. The Director of Data and Biostatistics will lead data operations for the Clinical Affairs team focused on medical devices, overseeing clinical data systems and statistical analysis of clinical study data to ensure regulatory compliance and data integrity.

Human ResourcesInformation TechnologyRecruiting

H1B Sponsor Likely

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

Qualification

Data management strategiesBiostatistics leadershipClinical data systemsStatistical analysis plansMedical device trialsFDA regulationsDatabase designData quality assuranceCommunication skillsProject managementTeam player

Required

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

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

Benefits

Medical

Dental

Vision

Life

Disability

Other insurance plans

ESPP (employee stock purchase program)

401K program

HSA (Health Savings Account on the HDHP plan)

SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions

Corporate discount savings program

Other discounts

On-demand training program

Access to certification prep

Library of technical and leadership courses/books/seminars

Certification discounts

Other perks to associations that include CompTIA and IIBA

Dedicated customer service team for our Consultants

Certified Career Coach

Company

Apex Systems

Glassdoor3.8

Apex Systems, a division of On Assignment, provides organizations with IT staffing solutions to address gaps in their current workforce.

Founded in 1995

Richmond, Virginia, USA

1001-5000 employees

https://www.apexsystems.com

H1B Sponsorship

Apex Systems has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (28)

2024 (21)

2023 (35)

2022 (26)

2021 (29)

2020 (38)