Essential Functions

• Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.

Qualifications

• with 3 years’ experience in an administrative environment or equivalent combination of education, training and experience.

Job Overview:

• As an Associate Biostatistics Director, you will be given access to cutting-edge, in-house technology and opportunities to work on global projects across a variety of therapeutic areas.
• Thanks to our development opportunities and mentoring at all levels, you will be able to progress your long-term career in the direction you choose.
• With global visibility, you will provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.
• You will serve as a resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials and assist the Director in strategic planning and resource allocation for the department.
• You will also participate as a Senior Statistician on major projects, including developing/reviewing protocols, preparing analysis plans, overseeing the conduct of analyses, and preparing integrated clinical and statistical reports.
• Along with assisting the Director in proposal development, project allocations, budget projections, and client presentation.

Requirements:

• BSc or MSc degree in Biostatistics or related field and 10+ years’ relevant experience within the life-science industry
• Familiarity with complex statistical methods that apply to Phase I-IV clinical trials
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Familiarity with moderately complex statistical methods that apply to applicable clinical trials
• Strong working knowledge of SAS
• Working knowledge of relevant Data Standards (such as CDISC/ADaM)