Coordinator, Biostatistics Operation Group

PTC Therapeutics, Inc.•Warren Township, NJ

About The Position

The Coordinator, Biostatistics Operation Group (BOG) performs system and process support activities for the PTC Biostatistics and Data Management (Biometrics) Department. This includes, but is not limited to, proactively and independently identifying, coordinating, and monitoring the administrative aspects of the BOG support function; performing ad-hoc and project-driven administrative tasks as assigned, utilizing administrative systems, processes and procedures and completing of routine activities. The incumbent will work cross-functionally with internal departments (including finance, accounts payable, accounts receivable, legal etc.) and external vendors/resources on computerized systems, processes, and related support areas. This includes but is not limited to; review and preparation of invoice payment, tracking consultants’ hours, preparing information for monthly accruals, communications with vendors to support, coordinating and supporting the Biostatistic department processes. When the Coordinator, Biostatistics Operation Group identifies opportunities for improvements, in a process, system or supporting framework, the Coordinator will communicate to BOG management. The Coordinator, Biostatistics Operation Group (BOG) supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

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 environment stated above.
Experience supporting large departments/groups in a fast-paced, dynamic, multicultural, international environment.
Detailed oriented and service minded.
Ability to handle confidential information with discretion.
Flexibility to work outside of core business hours when necessary.
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 (Power Point, 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.

Nice To Haves

Experience providing support for the administrative tasks associated with a clinical research/clinical operations function.
Experience with contract management software (i.e., Contracts 365) and service procurement systems (i.e., SAP Ariba).
Basic understanding of GxP regulations and of Data Integrity.

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.
Creates and has over-sight of 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 provide and ensure that service targets are met.
Participate in the 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 the PTC 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 that corrective actions are taken and confirm that the issues are resolved on a timely basis.
Create/Review and revise process documentation including SOPs and Work Instructions.
Perform other tasks and assignments as needed and specified by management.