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Associate Biostatistics Director - FSP (Permanent Home-based)

IQVIA -
Dublin, County Dublin

Apply Now

Job details

Full-time

Qualifications

Doctoral degree
SAS
SAP
R
Predictive analytics
Leadership
Communication skills

Full job description

Dublin, Ireland | Full time | Home-based | R1503450

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.

Apply Now

Refine Your Search

associate director, network contracting jobs in dublin, d

Associate Biostatistics Director - FSP (Permanent Home-based)

Senior Director, Risk & Controls (12 FTC)

Behavioural Threat Manager - Global Protection & Security (EMEA)

DBSO Director, Lean

Director/ Associate Director - Hotels, Sports & Leisure Construction Projects

Associate Director – M&E Cost Management Team

Associate Director - Enterprise Risk Management

Associate Director Building Surveyor

Associate Director - Landscape Architecture - Dublin/Cork

Sourcing Manager - 12 Month Fixed Term Contract

Senior Associate (Corporate Governance & Company Secretarial)

Senior Associate / Associate - Global Risks & Financial Lines (Complex Litigation) - Dublin

Associate, Corporate Investment Banking

Associate Director - Fund accounting

M&A Advisory - Associate Director

Associate Electrical Director: Data Centres

Imaging Operations Manager, Clinical Studies

Senior Sourcing Specialist, Professional Services

SENIOR CIVIL ENGINEER / ASSOCIATE DESIGNATE – DUBLIN OFFICE

Senior Manager Service Architect

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