Full-Time
Statistical Scientist Director
Premier Research International
1,001-5,000 employees
Contract research organization for clinical development
No salary listed
Italy
Hybrid
 Biology & Biotech (1) |
|---|
- Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field. Equivalent combination of education, training and experience will be considered.
- 15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment
- At least 1 yr technical experience in clinical trials design and analysis implementing innovative statistical analysis.
- Previous experience implementing innovative statistical designs
- Strong knowledge of regulatory, scientific, technical and clinical expertise in conduct of clinical trials in the respective area of focus as demonstrated by past positions related to the therapeutic area in the CRO and Pharma/Biotech sector
- Strong computer skills, with knowledge of advanced programming skills with standard software, including SAS, R
- Excellent working knowledge of CDISC standards and application of these standards to projects.
- Ability to manage and de-escalate difficult situations with clients, teams, and management
- Demonstrated experience in interacting with regulatory agencies (e.g., FDA, EMA, EU member states)
- Excellent English and Host Country Communication skills (verbal, written & interpersonal).
- Excellent organizational and time-management skills, able to prioritize work to handle multiple tasks and meet deadlines in a dynamic environment
- A willingness to travel, ~20%
- Serve as lead statistician on complex, key client studies, acting as point-of-contact, ensuring cohesive communication with sponsors and internal teams, and leading project-level statistical strategy from protocol/SAP planning through reporting, ensuring alignment of design, analyses, and data interpretation.
- Communicate complex quantitative concepts clearly to non-statistical stakeholders—including sponsor leadership, regulatory representatives, and clinical teams.
- Develops sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs.
- Develops or provides senior oversight for statistical deliverables, including: statistical selection of protocols, statistical Analysis Plans (SAPs), randomization specifications and Statistical contributions to CSRs, publications, and regulatory documents
- Identify risks related to study design, sample size, or analysis approaches and proactively propose mitigation strategies.
- Acts as project manager for biostatistics stand-alone work and drive high-quality statistical deliverables while managing budget, scope, and timeline expectations.
- Advise clients on regulatory guidelines, statistical principles for submissions, and global expectations (FDA, EMA, PMDA, etc.).
- Support business development through participation in bid defenses, capabilities presentations, RFP strategy and build trusted scientific relationships with sponsors and influence decision-making through evidence-based recommendations.
- Acts as an independent biostatistician on DSMBs and DMCs
Premier Research provides specialized clinical development services for biotech and specialty pharma, focusing on specific therapeutic areas where science is advancing. It supports end-to-end clinical trials, including study design, site management, data handling, statistics, regulatory affairs, and medical writing, across more than 20 countries with about 1,500 employees. Customers partner with Premier Research to plan and run development programs with cross-functional teams that design trials, manage sites and data, analyze results, and prepare regulatory submissions. The company aims to help biotech and pharma bring safe, effective therapies to patients faster by delivering high-quality clinical development and regulatory support.
Company Size
1,001-5,000
Company Stage
Acquired
Total Funding
$79.2M
Headquarters
Morrisville, North Carolina
Founded
1989
Your Connections
People at Premier Research International who can refer or advise you
Simplify's Take
What believers are saying
- Paul Spreen appointment as CCO drives sustainable growth from IQVIA experience.
- Milena Kanova-Petrova joins as SVP Global Head of General Medicine in April 2024.
- FDA Rare Disease Hub launched February 2026 enhances regulatory collaboration opportunities.
What critics are saying
- InSilicoTrials erodes trial revenue as AI simulates outcomes in 12-24 months.
- BioCentriq ties commoditize services against Lonza and WuXi scale in 18-36 months.
- FDA orphan guidances enable Parexel to capture rare disease share in 6-12 months.
What makes Premier Research International unique
- Premier Research specializes in rare diseases across 88 indications with orphan drug expertise.
- Partnerships with BioCentriq accelerate pre-IND cell therapy timelines since January 2024.
- InSilicoTrials collaboration integrates AI modeling to de-risk rare disease development.
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Benefits
Flexible Work Hours
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 3%2 year growth
↑ 18%Premier Research, a global clinical research and product development company, has appointed Paul Spreen as Chief Commercial Officer. Spreen brings over 25 years of life sciences leadership experience and will oversee global commercial strategy, business development, marketing and proposals. Spreen previously served as EVP and Chief Commercial Officer at IQVIA (formerly Quintiles), where he held several global leadership positions. His experience spans the full drug development lifecycle, from early discovery through commercialisation, with a focus on scaling organisations during periods of rapid growth and M&A. In his new role, Spreen will drive sustainable growth, strengthen customer engagement and advance Premier's position across the drug development spectrum. The Morrisville, North Carolina-based company specialises in clinical trials and regulatory strategy for the biotechnology sector.
MORRISVILLE, NC, April 1, 2024 – Premier Research is pleased to announce the addition of Dr. Milena Kanova-Petrova as Senior Vice President, Global Head of General Medicine. In this role, Dr. Kanova-Petrova will oversee strategic planning and project execution for all general medicine clinical operations inclusive of internal medicine, women’s health and dermatology.“Our customers are breaking barriers and forging new pathways every day in the pursuit of bettering patient care. The work is complex and specialized, and adding Dr. Kanova-Petrova to our Clinical Leadership Team expands the specialization that we can provide to our customers,” said Premier Research Chief Operating Officer, Michael Arlotto, Ph.D
Recruitment is essential for generating data on drug efficacy, which is crucial for the approval of new medical treatments. Clinical trial success hinges on the ability to recruit a sufficient and appropriate number of participants. As Cara Brant, chief executive officer (CEO) of Clinical Trial Media puts it, “Trials are intended to generate data on how a drug works and you can’t generate that data if you don’t have participants in the study. This makes recruitment one of the linchpins of clinical research and drug development as a whole.”However, the landscape of clinical trial recruitment is becoming increasingly competitive. With over 450,000 clinical trials in progress globally, according to Brant. The task of recruiting participants has never been more challenging
TrialHub, a leading platform for patient feasibility in clinical trials, is proud to announce its collaboration with Premier Research.
MORRISVILLE, N.C. and NEWARK, N.J., Jan. 8, 2024 /PRNewswire/ -- Premier Research, a preeminent global clinical research, product development, and consulting company, and BioCentriq, a renowned Contract Development and Manufacturing Organization (CDMO), have entered a strategic partnership to revolutionize the pre-Investigational New Drug (IND) process and accelerate the clinical translation of novel cell therapy products.Premier Research/BioCentriq LogoBy leveraging Premier Research's expertise in cell therapy product development and BioCentriq's proficiency in developing and manufacturing and testing cell therapies, the partnership will streamline the process of bringing new products to patients. As partners, Premier and BioCentriq are well positioned to support sponsors seeking to expedite the transition of their innovative cell therapy candidates from research to clinical trials."Partnering with BioCentriq aligns with our commitment to expediting the development of transformative cell therapies," stated Kenneth Ndugga-Kabuye, MD, FACMG, Vice President, Cell and Gene Therapy at Premier Research. "By merging our comprehensive product development expertise with BioCentriq's specialized capabilities we will help sponsors simplify the development process from pre-IND through approval, ultimately accelerating the delivery of innovative therapies to patients in need."This collaboration will harness Premier Research's comprehensive understanding of regulatory requirements, clinical trial design and study execution, alongside BioCentriq's specialized capabilities in cell therapy development."Cell therapy development is extremely complex," added Olu Aloba, PhD, Vice President, Chemical Manufacturing and Control (CMC) Services, Premier Consulting, a business unit of Premier Research, "Nonclinical and Clinical development, CMC, and the CDMO have to work hand in hand to address the scientific, logistical and regulatory demands that enable studies to generate high-quality results.""This collaboration marks a significant step in fostering a more streamlined pathway for groundbreaking cell therapies," remarked Alex Klarer, Vice President, Business Strategy and Innovation at BioCentriq. "Combining Premier Research's clinical insights with our CDMO expertise will empower us to expedite the translation of novel therapies from the lab to clinical reality, benefiting patients worldwide."About Premier ResearchPremier Research, a global clinical research, product development, and consulting company, is dedicated to helping biotech, specialty pharma, and medtech innovators transform life-changing ideas and breakthrough science into new medical treatments.Premier Research specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.Whether it's developing product lifecycle strategies, reducing clinical development cycle timelines, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier Research is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions