Remote Principal Biostatistician - Clinical Trial Design

IQVIA LLC; Durham (NC); Remote; USD 116,000 - 244,000; Full time

Benefits offered by this job

Remote work

Flexible schedule

Technical training

Career growth

Regulatory submissions

Long-term engagements

Job summary

IQVIA's Data Sciences Staffing Solutions (DSSS) is seeking a Principal Biostatistician to provide statistical support for pharmaceutical clinical trials in patients. This home-based role offers collaboration with cross-functional teams and exposure to regulatory submissions.

The candidate will perform sample size and power calculations, author SAPs, validate TLFs, and guide programmers while ensuring quality across IND/NDA activities. A PhD or MS with extensive industry experience is required.

Qualifications

• PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience.
• MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• At least 2 years in Phase 2/3 clinical trial experience.
• At least 3 years of experience in supporting simulations, sample size and power calculations
• Demonstrated ability to work pro-actively and independently.
• Able to effectively communicate statistical ideas and collaborate with cross-functional teams.
• Ability to efficiently use R or SAS to perform analyses.
• Support of various regulatory submissions.
• Understanding of relevant FDA guidance, ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• Experience in validation/programming of ADAM and TLF.
• Experience with CDISC, including SDTM, ADAM, CDASH.
• Solid understanding of estimands and multiple imputation methods.

Responsibilities

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Perform samples size and power calculations for optimizing study design
• Author statistical analysis plans.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Author or review analysis dataset and TLF specifications.
• Validation programming of efficacy analysis datasets plus tables, listings, and figures (TLF).
• Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc.
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.
• Participate in IND or NDA activities.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, SCE (Summary of Clinical Efficacy), SCS (Summary of clinical Safety).

Skills

Statistical analysis

Cross-functional collaboration

Regulatory communication

Independent working

R or SAS

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

R

SAS

ADAM/TLF validation

CDISC (SDTM/ADAM/CDASH)

Job description

IQVIA's Data Sciences Staffing Solutions (DSSS) is seeking a Principal Biostatistician to provide statistical support for pharmaceutical clinical trials in patients. This home-based role offers collaboration with cross-functional teams and exposure to regulatory submissions.

The candidate will perform sample size and power calculations, author SAPs, validate TLFs, and guide programmers while ensuring quality across IND/NDA activities. A PhD or MS with extensive industry experience is required.