Coordinator, Biostatistics Operation Group

Role Summary

The Coordinator, Biostatistics Operation Group (BOG) provides system and process support for the Biostatistics and Data Management (Biometrics) department. Responsibilities include coordinating administrative tasks, processing invoices, tracking consultant hours, and supporting monthly accruals; works cross-functionally with internal teams and external vendors. When opportunities for improvements are identified, communicates with BOG management. Supports adherence to regulatory requirements and SOPs.

Responsibilities

• Assist with the initiation, completion, management, and archiving of legal and financial documents for clinical programs, such as non-disclosure agreements, master services agreements, new vendor requests, vendor contracts, amendments, invoices and purchase orders.
• Provide general administrative support to the BOG function in its support of the study teams and department’s activities including:
• Oversee the monthly invoicing process.
• Review accruals with teams.
• Ensure contracts/work orders/amendments are created and approved in a timely manner.
• Create and oversee Purchase Orders.
• Collaborate with other departments.
• Format documents.
• Assist in signature collection.
• Interact with vendors to support the processing of invoices, documentation and agreements to support the Biostatistics department.
• Manage department electronic mailboxes and other resources.
• Oversee the Biostat Request system that tickets are assigned and resolved in a timely manner.
• Compile metrics on a regular basis for the Biostat Request system and ensure service targets are met.
• Participate in continued process improvement activities including invoices, contracts, RFPs, supporting system configurations, and the Biostat Request system.
• Assist in the delivery of support to the Biometrics Department by working closely with IT, Finance, Contracting, and Legal Departments to provide exceptional support and quick turn-around times.
• Participate in the assessment, selection, and evaluation of vendors.
• Ability to quickly understand and triage support questions and ensure corrective actions are taken and that issues are resolved in a timely manner.
• Create/review and revise process documentation including SOPs and Work Instructions.
• Perform other tasks and assignments as needed and specified by management.

Qualifications

• Bachelor’s Degree and a minimum of 3 years of relevant experience in a pharmaceutical, biotechnology, Contract Research Organization (CRO), university medical center, or related environment OR equivalent combination of experience and/or education in the environment stated above.
• Required: Special knowledge or skills and/or licenses or certificates required.
• Experience supporting large departments/groups in a fast-paced, dynamic, multicultural, international environment.
• Embrace new challenges and/or changed priorities and adjusts plans and priorities accordingly.
• Experience working in a fast growing and entrepreneurial environment.
• Demonstrated proficiency using the advanced functionality of Microsoft Office (PowerPoint, Excel and Word).
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and management skills, including the ability to support and prioritize multiple projects.
• Preferred: Special knowledge or skills and/or licenses or certificates preferred.
• Experience providing support for the administrative tasks associated with a clinical research/clinical operations function.
• Experience with contract management software (Contracts 365) and service procurement systems (SAP Ariba).
• Basic understanding of GxP regulations and of Data Integrity.

Education

• Bachelor’s Degree in a pharmaceutical/biotech/CRO or related field or equivalent combination of education and experience.

Additional Requirements

• Travel: 0–10%