RESPONSIBILITIES:
Kforce has a client in Acton, MA that is seeking a Director of Data and Biostatistics who will lead data operations for the Clinical Affairs team focused on medical devices. This role is responsible for overseeing the design, implementation, and maintenance of clinical data systems, ensuring data integrity, and supporting regulatory compliance across all clinical studies. Additionally, the Director of Data and Biostatistics will guide statistical analysis of clinical study data, applying appropriate methodologies to evaluate efficacy and safety and address research-related questions.
Responsibilities:
* Develop and execute data management strategies for clinical trials involving medical devices
* Support the design of clinical studies and ensure accurate interpretation of study data, collaborating cross-functionally to meet business needs
* Lead the creation and execution of statistical analysis plans for clinical studies
* Oversee the design and validation of clinical databases (e.g., EDC systems) to ensure compliance with study protocols and regulatory requirements
* Collaborate with teams including Clinical Operations, Medical Affairs, Regulatory Affairs, and Quality Assurance
* Ensure high-quality processes for data collection, cleaning, and reporting
* Manage data management and biostatistics vendors and CROs, ensuring timely and cost-effective deliverables
* Develop and maintain SOPs and best practices for biostatistics and data management activities
* Provide leadership and mentorship to data management and biostatistics staff, including direct reports
* Perform other duties as required
REQUIREMENTS:
* Master's degree in Life Sciences, Health Informatics, Biostatistics or related field
* 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
The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.
We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.
Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.
This job is not eligible for bonuses, incentives or commissions.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
By clicking ?Apply Today? you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers. Note that if you choose to communicate with Kforce via text messaging the frequency may vary, and message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You will always have the right to cease communicating via text by using key words such as STOP.
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: kforcecx
- Position Id: ITAQG2162133
- Posted 23 hours ago
Never miss an opportunity! Create an alert based on the job you applied for.
