Senior Biostatistician, Medical Affairs — Remote

IQVIA; Durham (NC); Remote; USD 111,000 - 309,000; Full time

Benefits offered by this job

Home-based remote

Flexible schedule

Collaborative teams

Tailored development curriculum

Research opportunities

Career trajectory

Regulatory submissions experience

Job stability

Work-life balance

Job summary

IQVIA, Data Sciences Staffing Solutions (DSSS), is seeking a Home-based Principal Biostatistician for US/Canada. This FSP role supports Phase 2/3 trials, offers collaborative cross-functional work with sponsor teams, and provides ongoing training, development, and long-term engagement opportunities.

You will author analysis plans, guide programmers, and contribute to publications while ensuring regulatory standards and data integrity in a fast-paced environment.

Qualifications

• PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
• MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
• At least 3 years in Phase 2/3 clinical trial experience.
• Demonstrated ability to work proactively and independently in a fast-paced environment.
• Able to effectively communicate ideas and to manage programmers in a constructive manner.
• Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
• Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• Experience with CDISC, including SDTM, ADAM, CDASH

Responsibilities

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Author statistical analysis plans.
• Collaborate with Biostatistics, Statistical Programming, Clinical Development, and Clinical Operations to provide statistical expertise.
• Contribute to publications and presentations.
• Provide guidance and supervision to programmers in planning and execution of analysis.
• Independently program or validate statistical outputs (tables, listings and figures) using SAS or R
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.

Skills

R

SAS

ICH GCP knowledge

CDISC (SDTM/ADAM/CDASH)

Communication

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Job description

IQVIA, Data Sciences Staffing Solutions (DSSS), is seeking a Home-based Principal Biostatistician for US/Canada. This FSP role supports Phase 2/3 trials, offers collaborative cross-functional work with sponsor teams, and provides ongoing training, development, and long-term engagement opportunities.

You will author analysis plans, guide programmers, and contribute to publications while ensuring regulatory standards and data integrity in a fast-paced environment.