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Cro Biostatistician Jobs in Basking Ridge, NJ (NOW HIRING)

micro1 AI

Director of Biostatistics

Jersey City, NJ · Remote

$60 - $65/hr

Preferred Qualifications * 5+ years as a biostatistician supporting clinical trials at a sponsor, CRO, or academic trials unit. * Hands-on experience producing or quality controlling TFLs for ...

micro1 AI

Director of Biostatistics

Elizabeth, NJ · Remote

$60 - $65/hr

Preferred Qualifications * 5+ years as a biostatistician supporting clinical trials at a sponsor, CRO, or academic trials unit. * Hands-on experience producing or quality controlling TFLs for ...

micro1 AI

Director of Biostatistics

New York, NY · Remote

$60 - $65/hr

Preferred Qualifications * 5+ years as a biostatistician supporting clinical trials at a sponsor, CRO, or academic trials unit. * Hands-on experience producing or quality controlling TFLs for ...

micro1 AI

Director of Biostatistics

Newark, NJ · Remote

$60 - $65/hr

Preferred Qualifications * 5+ years as a biostatistician supporting clinical trials at a sponsor, CRO, or academic trials unit. * Hands-on experience producing or quality controlling TFLs for ...

micro1 AI

Director of Biostatistics

Paterson, NJ · Remote

$60 - $65/hr

Preferred Qualifications * 5+ years as a biostatistician supporting clinical trials at a sponsor, CRO, or academic trials unit. * Hands-on experience producing or quality controlling TFLs for ...

Pfizer

Head of AI Clinical Excellence

New York, NY

$87K - $119K/yr

PhD in Life Sciences, Clinical Research, Data Science, Biostatistics, Computer Science, Engineering, or related field and 5+ years of relevant experience within pharmaceutical, biotechnology, CRO ...

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How much do cro biostatistician jobs pay per hour?

As of Aug 22, 2026, the average hourly pay for cro biostatistician in Basking Ridge, NJ is $59.31, according to ZipRecruiter salary data. Most workers in this role earn between $41.88 and $66.39 per hour, depending on experience, location, and employer.

What is a CRO biostatistician?

CRO Biostatisticians are statistical experts who work at Contract Research Organizations (CROs) to design, analyze, and interpret data from clinical trials and other research studies for pharmaceutical, biotechnology, and medical device companies. They ensure that studies are statistically sound and compliant with regulatory requirements. Their work is essential for determining the safety and efficacy of new drugs or treatments, and they collaborate closely with clinical teams, data managers, and regulatory agencies. CRO Biostatisticians also play a key role in preparing statistical analysis plans and contributing to regulatory submissions.

What are some common challenges faced by CRO biostatisticians when collaborating with cross-functional teams during clinical trials?

CRO Biostatisticians often work closely with clinical, data management, and regulatory teams, which can present challenges such as aligning statistical analysis plans with evolving study protocols, managing large and complex datasets, and ensuring clear communication of statistical concepts to non-statistical colleagues. Effective collaboration is essential, as miscommunication can impact timelines or data quality. Developing strong interpersonal and project management skills can help Biostatisticians navigate these challenges and contribute to successful clinical trial outcomes.

What are the key skills and qualifications needed to thrive as a CRO biostatistician, and why are they important?

To thrive as a CRO Biostatistician, you need a strong background in statistics, mathematics, and clinical research, typically supported by a master's or doctoral degree in biostatistics or a related field. Proficiency in statistical analysis software such as SAS, R, and understanding of CDISC standards are commonly required, along with knowledge of regulatory guidelines. Strong analytical thinking, attention to detail, and effective communication skills help in interpreting complex data and collaborating with multidisciplinary teams. These skills ensure the accuracy and integrity of clinical trial analyses, supporting regulatory submissions and successful drug development.

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Infographic showing various Cro Biostatistician job openings in Basking Ridge, NJ as of June 2026, with employment types broken down into 94% Full Time, 3% Part Time, and 3% Contract. Highlights an 76% Physical, 3% Hybrid, and 21% Remote job distribution, with an average salary of $123,360 per year, or $59.3 per hour.

Senior Manager, Biostatistics

Axsome Therapeutics

New York, NY • On-site

Full-time

Re-posted 2 days ago

Job description

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer's disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
About This Role
Axsome Therapeutics is seeking a Senior Manager, Biostatistics to provide statistical support for multiple neurology compounds across all phases of development. Reporting to the Senior Director, Biostatistics, the Senior Manager, Biostatistics will serve as lead statistician on assigned clinical trials, and in collaboration with project team members provide statistical input on trial design, protocol development, and manage creation of Statistical Analysis Plans (SAPs). Additionally, the Senior Manager, Biostatistics will manage Contract Resource Organization (CRO) partners in the creation of statistical outputs, with hands-on quality checks of the outputs. This role will contribute to Clinical Study Report (CSR) writing, and regulatory submission documents.
This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Job Responsibilities and Duties include, but are not limited to, the following:
  • Lead and manage all statistical activities within clinical studies (i.e. contributing to study design and selection of appropriate data analysis methods, sample size estimation)
  • Partner with other functional members, external consultants, key opinion leaders, medical advisors and CRO's/contractors, to ensure the quality and integrity of the data is maintained while identifying, and minimizing where possible, risks to the studies/projects
  • Collaborate with external CRO partners, manage creation of study SAPs based on regulatory guidance and sound statistical methodology, as well as creation of Table, Figure, and Listing shells, as per study timelines
  • Review Case Report Forms, and other supportive clinical trial documentation such as the Protocol Deviation Plan, and Data Management Plan.
  • Support clinical data reviews for data quality, outlier identification, trend analysis, and potential impact on trial results, using SAS and data visualization software, during trial conduct
  • Perform hands-on quality checks of CRO deliverables using SAS and/or R.
  • Contribute to CSR writing, including interpretation of trial results, and quality checks of data presentations.
  • Contribute to regulatory submission documents, including IND applications, FDA meeting briefing materials, and NDA submission documents, including eCRT packages.
  • Conduct ad hoc analyses using SAS and/or R in support of assigned projects.
  • Contributes to development of Standard Operating Procedures (SOPs), Work Instructions, and templates within function.
  • Ensure knowledge transfer during and at the completion of the studies/projects.
  • Stay up to date with changes in the field of statistics. Implements new ideas and advanced processes, where applicable.

Requirements / Qualifications
  • Master's degree or Ph.D. degree in Biostatistics, Statistics, Mathematics, or Medical Statistics, or a related discipline
  • At least 4 years of statistics experience with a Ph.D. degree or 7+ years with a Master's degree within the pharmaceutical industry (including contract research organizations (CROs)), biotechnology or medical sector, including clinical trial design, analysis and reporting
  • Experience in Phase III and III pivotal clinical development studies
  • Strong statistical programming skills in SAS
  • Ability to work on-site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Experience, Knowledge and Skills
  • Modeling and simulation skills are preferred
  • Strong ability to manage time and resources, ensuring the successful achievement of pre-determined deadlines
  • Flexibility in approach, while ensuring the delivery of high-quality work in a dynamic work environment, with competing priorities
  • Experience marketing application submissions to regulatory authorities is strongly preferred
  • Experience overseeing and managing CRO's statistical analysis of assigned clinical trials
  • Excellent communication and presentation skills (written and verbal)
  • Demonstrated ability to effectively interact with internal team members and external parties that do not possess the knowledge and background to readily understand the application of statistics to drug development and study outcomes

Salary & Benefits
The anticipated salary range for this role is $140,000-$170,000. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

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