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.
Are you a skilled biostatistician looking to make a meaningful impact in clinical development? Join a collaborative, cross-functional team where you'll help shape clinical trial strategy, drive statistical analyses, support regulatory submissions, and influence critical development decisions. This role offers the opportunity to work on complex studies, partner with global stakeholders, and apply innovative statistical approaches that advance therapies for patients.
This is a fully remote position, and candidates must be located in the United States.
The Biostatistician III/ Senior Biostatistician is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, biostatisticians can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBDS (Global Biometric Sciences) Biostatistics Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Biostatisticians are individual contributors and report to a
GBDS Lead.
The Biostatistician III is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician III has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.
Key Responsibilities:
- Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate.
- Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product.
- 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.
- Translates scientific questions into statistical terms and statistical concepts into layman terms.
- Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information.
- Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis.
- Communicates effectively with clinical and regulatory partners and external opinion leaders.
- Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents.
- Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted.
- Compliant with company’s processes and SOPs, global and project standards, and responsible for quality of deliverables.
- Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information.
- Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles.
- Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
- Drives alignment at study team level and escalates lack of team alignment to the GBDS Lead for resolution.
- Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions.
- Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
- Keeps up-to-date with state-of-the art applied statistical methodology. Understanding of CDISC standards and implementation guides.
Additional, Senior Level Responsibilities and Major Duties:
- Independently leads the development and execution of statistical aspects for multiple or complex studies.
- Leads portions of filing activities (e.g., multiple protocols, single indications) including planning for and execution of integrated analyses.
- Defends protocols and SAPs at PRC reviews and provides independent reviews.
Skills, Knowledge, and Experience:
Minimum Requirements:
- Master's degree in Statistics or equivalent & ≥ 6 years of industry related experience.
Or
- Ph.D. in Statistics or equivalent & ≥ 4 years of industry related experience.
Must Have
- Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals.
- Excellent verbal and written communications skills.
- Ability to be flexible and adapt quickly to the changing needs of the organization.
- Ability to organize multiple work assignments and establish priorities.
- Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.
Sr. Project Statistician Specifics
- Extensive knowledge of statistical / clinical trials methodology as it relates to clinical development.
- Demonstrated data analysis planning, execution and delivery experience in multiple clinical development setting, e.g. different diseases, indications, development phase.
- Past submission and regulatory interaction experience.
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.
Skills Required
- Master's degree in Statistics or equivalent and ≥ 6 years industry experience, or Ph.D. in Statistics or equivalent and ≥ 4 years industry experience.
- Extensive knowledge of statistical and clinical trials methodology as it relates to clinical development.
- Demonstrated data analysis planning, execution, and delivery experience in multiple clinical development settings (different diseases, indications, phases).
- Past submission and regulatory interaction experience.
- Understanding of CDISC standards and implementation guides.
- Ability to work successfully within global cross-functional teams leading to successful regulatory filings and approvals.
- Excellent verbal and written communication skills.
- Ability to be flexible, adapt quickly, organize multiple assignments, and establish priorities.
- Strong interpersonal skills with demonstrated ability to develop relationships across organizational levels.
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.
Parexel Insights
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.
