We are a recruiting company EasyHiring looking for candidates for the position of Director, Biostatistics in Princeton Junction, NJ for our partners.

Key Responsibilities

• Drives innovative and efficient study design. Develops study designs that address study objectives that will support regulatory approval, medical research and market access.
• Independently leads, initiates, and oversees the statistical support for the development of compounds within a therapeutic area
• Provides guidance and management to statisticians to ensure high quality and timely deliverables.
• Effectively engages as a matrix team member on high level development teams, to act as a scientific and strategic partner in the drug development process
• Contributes to Clinical Development Plans, leads GBDS related submission activities, and post-submission strategies/ preparations/defenses.
• Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information.
• Adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable
• Contributes to creation/maintenance of and provide training on statistical topics departmental SOPs.
• Provides guidance and management to statisticians to ensure high quality and timely deliverables.
• Manages a functional or project budget, and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards therein.
• Contributes to the statistical community of practice
• Provides active coaching to biostatistical team members when developing solutions to problems.
• Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
• Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.

Applicable to people managers

• Effectively engages as an employee advocate and management coach/mentor to team members both internally and externally
• Provides leadership to empower and develop the team.
• Provides guidance to employee's development plans and carries out performance review and feedback. Develops performance metrics for staff.

Qualifications & Experience

• PhD (9 years experience) or MS (11 years experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience
• Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
• Excellent interpersonal, communication, writing and organizational skills
• Demonstrate expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.
• Experience in preparing and participating in global regulatory agency interactions
• Demonstrate excellent collaboration, organizational/ leadership abilities, and interpersonal skills
• Demonstrate development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area.
• At least 3 years management (direct or matrix) experience is preferred (for people manager position only)

Job Type: Full-time

Work Location: On the road