Job#: 3013946

Job Description:

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions.

Apex has an opportunity for an Director of Data and Biostatistics. For applicants who are interested in this opportunity, send your updated resume to Mike Konjoian, Account Manager, at [email protected].

Here are the details:

Position: Director of Data and Biostatistics

Location: Acton, MA (must be local and available for on-site meetings)

Project Duration: 12 Months w/ potential for extension/conversion

Rate: Negotiable Based on Experience

JOB 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.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.