When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Remote- US | Full‑Time
About the RoleThe Principal Biostatistician works independently across clinical trial projects of all complexity levels, including those with major regulatory impact. This position is highly visible within the organization and to external partners and is recognized as a statistical expert. The ideal candidate is a strong communicator, trusted advisor, and technical leader capable of driving statistical strategy and execution across multiple therapeutic areas.
Key AccountabilitiesOperational Execution- Provide broad statistical support, including trial design, protocol development, and CRF development for assigned studies
- Lead production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports, and other supporting documentation
- Perform sample-size calculations, generate randomization lists, and write statistical methodology sections for study protocols
- Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and statistical analysis plans
- Serve in a supporting role as a non‑voting independent statistician, preparing data and analyses for DMC review
- This position is focusing on Patient-Report Outcomes (PRO)
- Support Business Development activities by contributing to study design discussions during internal and client meetings
- Provide and explain sample‑size scenarios
- Support proposal and budget development
- Attend and prepare for bid defense meetings
- Understand regulatory requirements across therapeutic areas and their implications for statistical methods, processing, and analysis
- Understand, apply, and provide training in extremely advanced and emerging statistical methods
- Contribute to the development and delivery of internal and external statistical training seminars and courses
- Review position papers in accordance with current good statistical practice
- Interact with clients and regulatory authorities
- Review publications and clinical study reports
- Travel to and actively contribute in client meetings (e.g., discussing analysis concepts or presenting study results)
- Perform additional responsibilities as defined by supervisor or manager
- Strong analytical skills
- Strong project management skills
- Professional attitude with excellent attention to detail
- Thorough understanding of statistical issues in clinical trials
- Ability to clearly describe advanced statistical techniques and interpret results
- Familiarity with regulatory and research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
- Prior experience with SAS programming required
- Ability to work independently
- Strong mentoring and leadership skills
- Strong business awareness and business development aptitude
- PhD or MS in Statistics or related discipline with substantial experience
- Knowledge of pharmacokinetic data is an advantage
- Competent in written and oral English, in addition to local language
- PhD in Statistics or related discipline, or
- MS in Statistics or related discipline
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
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What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
