Biostatistics Strategy Lead, FSP

IQVIA; Göteborgs kommun; On-site; SEK 1,400,000 - 2,000,000; Full time

Job summary

IQVIA is seeking a senior Biostatistics Lead to drive the statistical strategy for one or more therapeutic programs. You will oversee design, analysis and interpretation across clinical trials and regulatory submissions, collaborating with cross-functional teams to ensure robust statistical governance.

Candidates should have extensive experience in biostatistics within pharma/CRO settings, including adaptive designs, SAPs, and interactions with regulatory authorities.

Qualifications

• Minimum of 8 years of experience in clinical trial statistics.
• Experience with regulatory submissions and governance reviews.
• Strong knowledge of Bayesian methods, predictive modeling and simulations.

Responsibilities

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
• Define statistical strategy and ensure appropriate methodologies in study design and data analysis for clinical trials and regulatory submissions.
• Provide statistical thought partnership for innovative study design and clinical development plans including Go-No Go criteria and probability of technical success calculations.

Skills

SAS

R

Bayesian methods

Adaptive design

Study design

Statistical programming

Regulatory submissions

Education

PhD or MS in Biostatistics

Tools

SAS

R

Job description

IQVIA is seeking a senior Biostatistics Lead to drive the statistical strategy for one or more therapeutic programs. You will oversee design, analysis and interpretation across clinical trials and regulatory submissions, collaborating with cross-functional teams to ensure robust statistical governance.

Candidates should have extensive experience in biostatistics within pharma/CRO settings, including adaptive designs, SAPs, and interactions with regulatory authorities.