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• Responsible for overseeing all aspects of statistical planning and analyses for clinical programs; directs both internal and external SAS programming efforts related to the responsible clinical programs.
• MA or Ph.D. in (Bio)statistics. Requires 5 to 7 years of experience in pharmaceutical or biotechnology industry.
• Must have experience preparing analysis programs for clinical trials phases I-III.
• Must have been primary statistician on at least one NDA/BLA.
• Must have sound knowledge of statistical applications for clinical trials.
• Excellent writing and communication skills, and knowledge and skills of programming important.
• Strong knowledge of and experience in clinical trials design.
• Very good knowledge of drug development regulations pertinent to trial design and statistical analysis.

• Proficiency in R, SAS, and/or Python, with demonstrated expertise in developing, validating, and implementing statistical analyses and simulation studies, such as ANCOVA, multiple imputation (MI), multiplicity control (type I error control, power calculation).
• Solid understanding of statistical theory and hands-on experience with statistical computing, simulations, and data interpretation
• Ability to independently lead statistical activities and also work in a collaborative environment.

• Master or PhD in Statistics or Biostatistics (PhD preferred)

DefinedTalent is looking for a Sr. Biostatistician to join one of their clients that is transforming clinical data workflows with multi agent ai and automation; cutting cycle times, reducing cost and ensuring compliance. This is a senior individual-contributor role. You’ll own the statistical thinking on trials from start to finish, covering design, endpoints, specifications, outputs, and interpretation. You’ll write the deliverables yourself rather than review work others produce.

Generative AI and coding agents are part of daily statistical work here, and your judgment decides whether the resulting analyses are correct. Instead of a traditional clinical matrix, you’ll work mostly with our AI and software engineers, applying our AI-driven biostatistics platform to real clinical programs.

Responsibilities:
Write the core statistical deliverables for Phase I–III trials, including Statistical Analysis Plans, analysis specifications, TLF shells, and the documentation that takes a study from protocol to final outputs

Own decisions on design, endpoints, estimands, analysis methods, missing data, and sensitivity analyses, and justify them against regulatory expectations

Review analysis datasets, specifications, outputs, and code, including AI-generated work, for statistical soundness, consistency, and traceability before release

Use generative AI and coding agents every day to write and modify SAS or R code, explore unfamiliar problems, debug, and iterate to working analyses, while staying accountable for the correctness of the implementation

Partner closely with AI and software engineers to turn statistical intent into product behavior and stress-test what models and pipelines produce, working across SDTM, ADaM, and TLF production rather than in a statistics silo

Apply frontline statistical judgment to our platform by using it on live clinical programs

Requirements

• Substantial hands-on experience as a trial statistician in clinical development, an advanced degree in a quantitative field, and the independence to reason through design, endpoints, estimands, methods, missing data, sensitivity analyses, and interpretation
• Must-have: personal authorship of major statistical deliverables (SAPs, analysis specifications, TLF shells, and related documentation), plus a working understanding of how the protocol, SAP, analysis datasets, specifications, and final outputs connect. Reviewing or approving others’ work does not substitute for this.
• A skeptical, critical mindset. You question assumptions, follow up on inconsistencies, examine outputs closely, and notice when a result doesn’t make statistical sense. You don’t trust code, software output, or AI-generated work just because it ran.
• Comfort with SAS and/or R using modern AI-assisted development tools, and the statistical judgment to inspect, modify, debug, and validate the results. AI fluency is required here. We are not looking for an ML engineer or AI architect.
• Practical working knowledge of CDISC, especially ADaM, plus familiarity with SDTM and the broader clinical data and statistical programming workflow
• A solid grasp of FDA and EMA expectations for statistical analyses and deliverables. We value this more than having personally led a submission.
• High autonomy and a can-do attitude. When you hit an unfamiliar statistical, data, or technical problem, you investigate it, form a view, and work toward a practical solution instead of passing it off.
• Clear communication with engineers, clinical teams, and client stakeholders, and the ability to move easily between methodology, specifications, data, outputs, and AI tooling
  

Nice to Have

• Exposure to NDA/BLA submissions or direct interaction with the FDA or other health authorities
• Experience building, specifying, or shaping statistical software, tools, or automation
• Experience in a startup or small, fast-moving team where the problem defines the scope, not the job title

Benefits

• Help redefine how biostatistics and clinical trial delivery work through AI
• Work with experienced scientists and engineers from leading pharma and top tech companies, with broad scope and real autonomy over how the statistics get done
• Directly shape our core product and client delivery during a period of rapid growth
• Competitive compensation and equity, plus comprehensive benefits
• Comprehensive health insurance (medical, dental, vision)
• 401(k) retirement plan with company contribution
• Generous paid time off and holidays
• Opportunities for rapid professional growth in a high-impact, scaling organization
• Collaborative, flat organizational culture with direct access to leadership
• Professional development and training support

Job Title: Biostatistician
Duration: 6 Months
Location: Parsippany, NJ
Candidates may be required to work onsite for a few days during the assignment, with the remaining time being fully remote.

Job Description:
The role is responsible for conducting biostatistical activities to support all phases of clinical development and post-marketing efforts. This role will collaborate closely with other biostatisticians, statistical programmers, and cross-functional team members, as well as with contract research organization (CRO) partners and other vendors to meet company R&D objectives. Individuals in this role will support the development and review of statistical deliverables and provide high-quality analytical outputs to inform clinical and regulatory decision-making
 
Knowledge, Skills, and Abilities:
Strong understanding of clinical trial design principles, including adaptive designs.
Ability to effectively communicate complex statistical analyses and concepts to non-statisticians in non-technical language.
Ability to balance scientific rigor with operational and business considerations in a fast-paced development environment.
Knowledge and extensive hands-on experience with CDISC methodologies and industry data standards including SDTM and ADAM.
Demonstrated ability to manage multiple priorities and timelines while delivering high-quality outputs.
Working knowledge of regulatory guidelines and expectations in pharmaceutical development; experience supporting regulatory interactions is a plus.
Programming experience in SAS is required; experience in R is a plus.
Familiarity with real-world evidence and observational research methodologies (e.g., causal inference) is a plus.
Prior experience supporting clinical development programs in acute or chronic pain indications is a plus.
Understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.
  
Education
Master’s Degree in statistics, biostatistics from accredited college or university
Minimum 4 years of experience within the biotech/pharmaceuticals industry or a related field.
Experience in statistical responsibilities for design, analysis, and reporting of randomized controlled trials.

Duration: 07 Months—Possible extension

Description:

The role is responsible for conducting biostatistical activities to support all phases of clinical development and post-marketing efforts. This role will collaborate closely with other biostatisticians, statistical programmers, and cross-functional team members, as well as with contract research organization (CRO) partners and other vendors to meet company R&D objectives. Individuals in this role will support the development and review of statistical deliverables and provide high-quality analytical outputs to inform clinical and regulatory decision-making.

Knowledge, Skills, and Abilities:

• Strong understanding of clinical trial design principles, including adaptive designs.

• Ability to effectively communicate complex statistical analyses and concepts to non-statisticians in non-technical language.

• Ability to balance scientific rigor with operational and business considerations in a fast-paced development environment.

• Knowledge and extensive hands-on experience with CDISC methodologies and industry data standards including SDTM and ADAM.

• Demonstrated ability to manage multiple priorities and timelines while delivering high-quality outputs.

• Working knowledge of regulatory guidelines and expectations in pharmaceutical development; experience supporting regulatory interactions is a plus.

• Programming experience in SAS is required; experience in R is a plus.

• Familiarity with real-world evidence and observational research methodologies (e.g., causal inference) is a plus.

• Prior experience supporting clinical development programs in acute or chronic pain indications is a plus.

• Understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.

Education and Experience:

• Master’s Degree in statistics, biostatistics from accredited college or university

• Minimum 4 years of experience within the biotech/pharmaceuticals industry or a related field.

• Experience in statistical responsibilities for design, analysis, and reporting of randomized controlled trials.

About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit (url removed).

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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