Biostatistics Lead for Clinical Trial Strategy

IQVIA; København; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

IQVIA is seeking a senior Biostatistician to lead its biostatistics program within a therapeutic area, guiding statistical strategy for design and regulatory submissions. You will collaborate with cross-functional teams, influence development plans and ensure timely delivery of analyses.

Ideal candidates have 8+ years in clinical trial statistics, strong SAS/R skills, and experience with adaptive designs, go/no-go criteria, and regulatory interactions. This role is based in Denmark.

Qualifications

• PhD or MS in Biostatistics, Statistics or related field.
• Minimum of 8 years of experience in clinical trial statistics, preferably within a pharmaceutical or CRO setting.
• Advanced proficiency in SAS / R for data analysis and statistical programming.
• Experience with Bayesian methods, predictive modeling, and simulation techniques.
• Proven track record in strategic study design, including adaptive designs, sample size calculations, and interim analysis planning.
• Familiarity with regulatory guidance on statistical methodologies (FDA, EMA, PMDA).
• Solid experience in applications of advanced statistical methodologies
• Leading roles in regulatory submissions
• Experience in interactions with major regulatory authorities preferred
• Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
• Study Design and Strategy: lead discussions during protocol development and study planning.
• Skilled in defining SAP and developing strategic approaches for complex study designs.
• Experience in strategy discussions involving adaptive design, go/no-go criteria, and futility analyses.
• Collaboration and Communication: present statistical concepts to cross-functional teams.
• Proven experience in collaborating with clinical and regulatory teams to align statistical strategy with program objectives.

Responsibilities

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
• Define statistical strategy and ensure appropriate statistical methodologies for study design and data analysis for clinical trials and regulatory submissions.
• Influence and contribute to clinical development plans, collaborate with cross-functional teams for governance reviews.
• Lead statistical strategy for planning and study execution and quantitative evaluation to trials, regulatory submissions, and related documents.
• Provide statistical thought partnership for innovative study design and development plans, including Go-No Go criteria and probability of technical success calculations.
• Plan analyses across projects; ensure quality and timely delivery of interim and final results, including integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities (FDA, EMA, PMDA).
• Interpret analysis results and ensure reporting accuracy in study reports and regulatory documents.
• Prepare abstracts, posters, oral presentations and reports to communicate results to stakeholders with varying levels.

Skills

Biostatistics

SAS / R

Bayesian methods

Study design

Regulatory submissions

Leadership

Communication skills

Education

PhD or MS in Biostatistics, Statistics or related field

Tools

SAS

R

Job description

IQVIA is seeking a senior Biostatistician to lead its biostatistics program within a therapeutic area, guiding statistical strategy for design and regulatory submissions. You will collaborate with cross-functional teams, influence development plans and ensure timely delivery of analyses.

Ideal candidates have 8+ years in clinical trial statistics, strong SAS/R skills, and experience with adaptive designs, go/no-go criteria, and regulatory interactions. This role is based in Denmark.