We are a recruiting company EasyHiring looking for candidates for the position for Associate Director, Biostatics in Middlesex, NJ work in Middlesex, NJ

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at our clients is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Director of Biostatistics is a member of cross-functional team and contributes to development of compounds within a therapeutic area. Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access. Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defenses. Provides guidance and management to statisticians to ensure high quality and timely deliverables. Manages resources, sets priorities, and ensures consistency and adherence to standards therein.

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
• Presents and defends complex statistical solutions to all levels of our clients governance, key stakeholders and external regulatory bodies in a clear, concise, complete, and transparent manner that provide influence on key decisions
• 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.
• Compliant with our clients processes and SOPs, 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.
• Represents our clients at professional societies, and in industry-wide technical discussions.
• 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)

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every our clientsemployee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Job Type: Full-time

Work Location: On the road