Sr/Principal Statistician (Sponsor-dedicated) Many possible locations (EMEA)

Are you a seasoned statistician with a passion for accelerating drug development, eager to make a direct impact within an innovative environment? Picture yourself at the forefront of early-phase clinical trials, working hand-in-hand with a dedicated sponsor to bring life-changing therapies closer to patients. At Syneos Health, we're building a team of problem solvers who thrive on complexity and collaboration. This unique remote opportunity in EMEA invites you to leverage your expertise in a role where your statistical insights directly shape the future of medicine, all while enjoying the flexibility and support of a truly forward-thinking organization.

Overview

Syneos Health stands as a premier, fully-integrated life sciences services organization, committed to propelling our customers' success. Our Clinical Solutions team comprises individuals with a deep drug development mindset, translating their extensive experience and specialized knowledge into practical, effective solutions. In this pivotal Sr/Principal Statistician role, you will immerse yourself in an exclusive sponsor-dedicated partnership, focusing specifically on early-phase projects. This is a fully remote position for candidates based anywhere in the EMEA region, offering an unparalleled chance to contribute to vital research from the comfort of your home office, backed by a global leader in clinical development.

Key Responsibilities

Lead and contribute to the statistical design and methodology of early-phase clinical trials, ensuring scientific rigor and integrity.
Develop comprehensive Statistical Analysis Plans (SAPs), ensuring alignment with study protocols and regulatory requirements.
Perform complex statistical analyses and interpret results with precision, transforming data into actionable insights for the sponsor.
Actively participate in the review of Case Report Forms (CRFs), TFL shells, and other critical study documentation.
Collaborate directly with cross-functional teams, including clinicians, data managers, and regulatory affairs specialists, fostering strong partnerships.
Serve as the primary statistical point of contact for the dedicated sponsor, offering expert guidance and strategic input.
Provide mentorship and technical leadership to junior statisticians and team members, cultivating a culture of excellence.
Contribute to the preparation of clinical study reports, regulatory submissions, and scientific publications.
Ensure all statistical activities adhere to ICH guidelines, Good Clinical Practice (GCP), and other relevant regulatory standards.

Requirements

An advanced degree (Master's or Ph.D.) in Biostatistics, Statistics, or a closely related quantitative field.
Substantial experience as a Biostatistician within the pharmaceutical, biotechnology, or CRO industry, with a strong focus on early-phase clinical trials.
Proven expertise in various statistical methodologies relevant to drug development.
Proficiency in statistical programming languages, particularly SAS and/or R.
Demonstrated ability to work independently and effectively manage multiple projects in a fast-paced environment.
Exceptional communication and interpersonal skills, capable of explaining complex statistical concepts clearly to diverse audiences.
Thorough understanding of regulatory requirements for clinical trials (e.g., ICH guidelines, FDA, EMA).
Prior experience working in a sponsor-dedicated or FSP model is highly advantageous.

What You'll Gain

The profound satisfaction of contributing to groundbreaking early-phase research, directly impacting patient lives.
Outstanding opportunities for career development and progression within a rapidly growing global organization.
A supportive and collaborative work environment where your contributions are valued and recognized.
Direct engagement with a key sponsor, offering unique insights and influence in drug development decisions.
The flexibility and autonomy of a fully remote role within the EMEA region, promoting an excellent work-life balance.
Access to continuous learning, including technical and therapeutic area training, to further hone your expertise.