
Associate Biostatistics Director - FSP (Permanent Home-based)
IQVIA
Associate Biostatistics Director - FSP (Permanent Home-based)
Lead Biostatistics for clinical programs in a fully remote FSP role. Requires PhD/MS in Biostatistics, 8+ years experience, and expertise in SAS/R, Bayesian methods, and regulatory submissions. Strategic study design and cross-functional collaboration are key.
RemoteFull-timeSeniorSASR
Associate Biostatistics Director - FSP (Permanent Home-based)
Lead Biostatistics for clinical programs in a fully remote FSP role. Requires PhD/MS in Biostatistics, 8+ years experience, and expertise in SAS/R, Bayesian methods, and regulatory submissions. Strategic study design and cross-functional collaboration are key.
RemoteFull-timeSeniorSAS
Salary
Not specified
Core Qualifications
Technical (Must-have)
SASRBayesian methodspredictive modelingsimulation techniquesadaptive designssample size calculationsinterim analysis planningstatistical analysis plans (SAP)
Soft Skills
leadershipcommunicationcollaboration
Key Responsibilities
- 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 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.
- 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.
Associate Biostatistics DirectorFSPPermanent Home-basedRemoteClinical TrialsBiostatisticsSASRRegulatory SubmissionsIQVIA