Associate Biostatistics Director - FSP (Permanent Home-based)

IQVIA; København; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

IQVIA is seeking a senior Biostatistician to lead the full scope of statistical conduct for the designated program. You will shape the strategic statistical approach for trial design, data analysis, and regulatory submissions, collaborating across Clinical Development and Study Executives.

You will provide expert statistical partnership for innovative study design, Go/No-Go criteria, and adaptive designs, interfacing with regulatory authorities to ensure robust, timely results and clear

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).
• Leading roles in regulatory submissions and collaboration with regulatory authorities.

Responsibilities

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area and define statistical strategy.
• Collaborate with cross-functional teams for governance reviews and study execution.
• Provide statistical thought partnership for innovative study design and Go-No Go criteria.
• Plan analyses and ensure timely delivery of interim and final results 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.

Skills

Bayesian methods

Adaptive designs

Go/No-Go criteria

Regulatory strategy

Statistical leadership

Education

PhD or MS in Biostatistics, Statistics or related field

Tools

SAS

R

Job description

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
• Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
• Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
• Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
• Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
• Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
• Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
• Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
• Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge

Education

• PhD or MS in Biostatistics, Statistics or related field

Experience

• Minimum of 8 years of experience in clinical trial statistics, preferably within a pharmaceutical or CRO setting.
• Technical Expertise:
• 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 (e.g., 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:
• Ability to lead statistical discussions during protocol development and study planning.
• Skilled in defining statistical analysis plans (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:
• Strong communication skills to effectively present statistical concepts to cross-functional teams.
• Proven experience in collaborating with clinical and regulatory teams to align statistical strategy with overall program objectives.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.