Apex Systems
Join to apply for the
Director of Data and Biostatistics
role at
Apex Systems
Job #: 3013946
Base pay range $115.00/hr - $143.00/hr
Job Description Apex Systems is a world‑class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions.
We are seeking a
Director of Data and Biostatistics
to lead data operations for our Clinical Affairs team focused on medical devices. The role will oversee the design, implementation, and maintenance of clinical data systems, ensure data integrity, and support regulatory compliance across all clinical studies. Additionally, the director will manage the statistical analysis of clinical study data, ensuring appropriate methods and accurate analyses to evaluate efficacy and safety.
Position Details Location:
Acton, MA (must be local and available for on‑site meetings)
Project Duration:
12 months with potential for extension/conversion
Rate:
Negotiable based on experience
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 data, working cross‑functionally to meet business needs.
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 protocols and regulatory requirements.
Collaborate with 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; the role will have direct reports.
Perform other duties as required.
Education and Experience
Master’s degree in Life Sciences, Health Informatics, Biostatistics, or a 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 knowledge of FDA and ISO regulations (e.g., 21 CFR Part 11, ISO 14155).
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 and Competencies
Excellent written and verbal communication skills.
Ability to communicate cross‑functionally across the organization.
Proficiency with PC tools including word processing, spreadsheets, and databases.
Flexible and able to work in a fast‑paced environment.
Team player with strong organizational and prioritization skills.
Excellent ability to generate and maintain accurate records.
Benefits include medical, dental, vision, life, disability and other insurance plans; 401(k) with company match; health savings account; employee assistance program; and professional development resources. For a full list of benefits, please refer to our Welcome Packet.
Seniority Level Director
Employment Type Full‑time
Job Function Research, Analytics, and Information Technology
Industries IT Services and IT Consulting
Apex Systems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with applicable law.
If you require an accommodation with our website, please contact our Employee Services Department at
[email protected]
(do not submit resumes to this address).
#J-18808-Ljbffr
Director of Data and Biostatistics
role at
Apex Systems
Job #: 3013946
Base pay range $115.00/hr - $143.00/hr
Job Description Apex Systems is a world‑class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions.
We are seeking a
Director of Data and Biostatistics
to lead data operations for our Clinical Affairs team focused on medical devices. The role will oversee the design, implementation, and maintenance of clinical data systems, ensure data integrity, and support regulatory compliance across all clinical studies. Additionally, the director will manage the statistical analysis of clinical study data, ensuring appropriate methods and accurate analyses to evaluate efficacy and safety.
Position Details Location:
Acton, MA (must be local and available for on‑site meetings)
Project Duration:
12 months with potential for extension/conversion
Rate:
Negotiable based on experience
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 data, working cross‑functionally to meet business needs.
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 protocols and regulatory requirements.
Collaborate with 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; the role will have direct reports.
Perform other duties as required.
Education and Experience
Master’s degree in Life Sciences, Health Informatics, Biostatistics, or a 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 knowledge of FDA and ISO regulations (e.g., 21 CFR Part 11, ISO 14155).
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 and Competencies
Excellent written and verbal communication skills.
Ability to communicate cross‑functionally across the organization.
Proficiency with PC tools including word processing, spreadsheets, and databases.
Flexible and able to work in a fast‑paced environment.
Team player with strong organizational and prioritization skills.
Excellent ability to generate and maintain accurate records.
Benefits include medical, dental, vision, life, disability and other insurance plans; 401(k) with company match; health savings account; employee assistance program; and professional development resources. For a full list of benefits, please refer to our Welcome Packet.
Seniority Level Director
Employment Type Full‑time
Job Function Research, Analytics, and Information Technology
Industries IT Services and IT Consulting
Apex Systems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with applicable law.
If you require an accommodation with our website, please contact our Employee Services Department at
[email protected]
(do not submit resumes to this address).
#J-18808-Ljbffr