Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you!  

 

Are you a leader in biostatistics looking to make a global impact? QPS is searching for a Senior Director of Biostatistics to shape the strategic direction of our biostatistics function and elevate clinical trial innovation. If you thrive on collaboration, possess a strategic mindset, and excel in guiding teams to success, we invite you to join our mission of advancing drug development.

 

QPS’ Story:

Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

 

Team members enjoy challenging and rewarding work, and are encouraged achieve their best.  Underpinning the operation is a culture that values diversity, innovation, accountability, team work and a friendly atmosphere where performance is recognized and rewarded.  We provide unique company benefits, training, and advancement opportunities.  Most importantly, we value each of our team members as employees and as individuals.

 

If this sounds like your ideal work environment, then we would love to speak with you, so apply today! Please visit our website (www.qps.com) for more information and to see all current openings.

 

The Job

As the Senior Director of Biostatistics, you will oversee all biostatistical functions across QPS clinical trials globally. Reporting to the senior leadership team, you’ll play a pivotal role in designing and delivering high-quality, regulatory-compliant statistical analyses to drive clinical development goals. You'll lead a team of statisticians while collaborating with cross-functional teams across the globe. 

Lead Strategy: Develop and implement global policies, procedures, and standards for biostatistical operations.Ensure Compliance: Align biostatistical deliverables with FDA, EMA, PMDA, GCP, and ICH regulations.Support Clinical Excellence: Design and approve statistical analysis plans (SAPs), sample size justifications, and clinical trial protocols.Collaborate Globally: Partner with functional heads, site leaders, and clients across QPS’ international network to align biostatistics strategies with organizational goals.Mentor Teams: Manage and develop a global team of biostatisticians, fostering professional growth and ensuring alignment with QPS objectives.Client Engagement: Represent QPS in client interactions, facility visits, and audits, showcasing our capabilities in biostatistics.Innovate Solutions: Provide technical and strategic leadership to enhance operational efficiency and clinical trial sophistication.

 

Work Location

This job may be 100% home-office based.   (see Telecommuting Policy for full details)

 

Requirements

We’re seeking a results-driven leader with a strong background in biostatistics and clinical development. The ideal candidate will bring: 

Regulatory Expertise: In-depth knowledge of GCP, ICH, FDA regulations, and clinical drug development and approval processes. Experience interacting with regulatory agencies is essential.Technical Proficiency: Expertise in SAS, Phoenix WinNonlin, Kinetica, and advanced skills in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).Scientific Communication: Strong written and verbal communication skills, with a command of medical terminology, scientific writing, and presentation development.Leadership Excellence: Proven ability to manage and mentor teams in a global drug development environment, with direct experience in task assignment, performance management, and employment decisions.Client-Centric Approach: Skilled in assessing client needs, meeting quality standards, and ensuring client satisfaction under tight timelines and pressure.Collaborative Spirit: Demonstrated ability to thrive in global, cross-functional teams, employing active listening and fostering a collaborative work environment.Educational Foundation: An advanced degree in pharmaceutical research, biostatistics, or a related scientific field is preferred. A minimum of 10 years of relevant experience in the pharmaceutical or CRO industry is ideal.

 

Why You Should Apply

Great learning opportunities, especially for those new to the field.  Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.Structured Career Ladders that provide excellent growth based on your personal aspirations.Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability InsurancePark-like setting in Newark, DelawareInternal committees designed with the needs and enjoyment of QPS employees in mind.

 

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer.  In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.