Remote Principal Biostatistician, Medical Affairs (Phase 2/3)

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

Benefits offered by this job

Home-based remote work

Flexible schedules

Technical training

Research opportunities

Long-term engagements

Job summary

IQVIA DSSS is seeking a Principal Biostatistician to support Phase 2 and 3 trials from a home-based role in the U.S. or Canada. You will collaborate with cross-functional teams, author SAPs, and guide programmers using SAS or R, with opportunities for publications and regulatory submissions.

Expect to contribute to trial analyses, ensure data integrity, and engage in a fast-paced, growth-oriented environment with long-term engagements and comprehensive benefits.

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 communicate his/her 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

Effective communication

Independent work in fast-paced env

Proactive mindset

Education

PhD in Statistics/Biostatistics or related field

MS in Statistics/Biostatistics or related field

Tools

R

SAS

CDISC SDTM/ADAM/CDASH

Job description

IQVIA DSSS is seeking a Principal Biostatistician to support Phase 2 and 3 trials from a home-based role in the U.S. or Canada. You will collaborate with cross-functional teams, author SAPs, and guide programmers using SAS or R, with opportunities for publications and regulatory submissions.

Expect to contribute to trial analyses, ensure data integrity, and engage in a fast-paced, growth-oriented environment with long-term engagements and comprehensive benefits.