Director of Retention – Casino, Realsports
Sporty Group
Associate Biostatistics Director – FSP
IQVIA
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇬🇧 United Kingdom
Visit company websiteJob Level
Lead
Tech Stack
Go
About the role
- 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.
Requirements
- 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 (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.
Benefits
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
BiostatisticsStatisticsSASRBayesian methodspredictive modelingsimulation techniquesadaptive designssample size calculationsinterim analysis planning
Soft skills
leadershipcommunicationcollaborationstrategic thinkinganalytical skillsproblem-solvinginfluencingpresentation skillsreporting accuracystakeholder engagement
Certifications
PhD in BiostatisticsMS in Statistics
