Biostatistics

Spectrum Staffing Services

Denville (NJ)

Remote

USD 110,000 - 140,000

Full time

3 days ago
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Benefits offered by this job

Flexible remote work
Hybrid work arrangement
Professional collaboration with CROs

Job summary

Spectrum Staffing Services seeks an experienced Biostatistician to support statistics across clinical development and post-marketing programs in a pharmaceutical environment. This contract role offers flexible remote/hybrid work and opportunities to contribute to trial design, analysis, reporting, and regulatory deliverables.

You will collaborate with biostatistics, programming, CROs, and external partners, perform SAS analyses, CDISC SDTM/ADaM work, and translate complex statistics for

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.

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.
  • 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.

Skills

CDISC SDTM/ADaM
SAS programming
Regulatory experience
R knowledge
Clinical trial design
Communication skills

Education

Master’s in Statistics/Biostatistics

Tools

SAS
R

Job description

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.
  • 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.
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