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Job description
SUMMARY
We are seeking an experienced Biostatistician to support statistical activities across clinical development and post-marketing programs within a pharmaceutical environment. This contract opportunity offers a flexible remote/hybrid work arrangement and the chance to contribute to clinical trial design, analysis, reporting, and statistical deliverables used to support key clinical and regulatory decisions. The position will collaborate with biostatistics, statistical programming, cross-functional teams, CROs, and external partners.
RESPONSIBILITIES
Perform biostatistical activities supporting clinical development and post-marketing programs.
Support the statistical design, analysis, and reporting of randomized controlled clinical trials.
Develop, review, and ensure quality of statistical deliverables.
Apply clinical trial design principles, including adaptive design concepts.
Utilize CDISC standards, including SDTM and ADaM, across clinical data and statistical activities.
Perform statistical programming and analysis using SAS.
Partner with internal teams, CROs, programmers, and other external vendors.
Clearly communicate statistical findings and concepts to both technical and non-technical stakeholders.
Manage multiple projects and deadlines while maintaining quality and accuracy.
Follow established pharmaceutical biostatistics procedures and quality-control standards.
QUALIFICATIONS
Master’s degree in Statistics, Biostatistics, or a closely related discipline.
Professional biostatistics experience within pharmaceutical, biotechnology, or a closely related industry.
Hands-on experience with the design, analysis, and reporting of randomized controlled trials.
Strong knowledge of CDISC methodologies, SDTM, and ADaM.
Advanced SAS programming and statistical analysis skills.
Solid understanding of clinical trial design and statistical methodology.
Ability to translate complex statistical concepts for non-statistical audiences.
Experience with R is preferred.
Regulatory interaction or pharmaceutical regulatory experience is a plus.
Exposure to real-world evidence, observational research, or causal inference methodologies is beneficial.
Experience supporting clinical programs involving acute or chronic pain is a plus.
BENEFITS
Flexible remote/hybrid work arrangement, with fully remote consideration for highly qualified candidates.
Opportunity to contribute to meaningful clinical development and post-marketing programs.
Exposure to statistical work supporting important clinical and regulatory decision-making.
Collaborative environment working alongside experienced biometrics, programming, clinical, CRO, and cross-functional professionals.
Opportunity to strengthen expertise in clinical trial methodology, CDISC standards, SAS, and regulatory-focused biostatistics.
Full-time contract assignment with consistent EST business hours and flexibility for primarily remote work.
Worksite address
township of denville, NJ, 07834, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.