Senior/Executive Director of Biostatistics @ Kaye/Bassman International | Jobright.ai
JOBSarrow
RecommendedLiked
0
Applied
0
External
0
Senior/Executive Director of Biostatistics jobs in United States
53 applicantsPosted by Agency
company-logo

Kaye/Bassman International · 3 days ago

Senior/Executive Director of Biostatistics

ftfMaximize your interview chances
ConsultingHuman Resources
Hiring Manager
Jim Brennan
linkedin

Insider Connection @Kaye/Bassman International

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Team oversight in budget and hiring
Responsible for randomization specifications, QC the dummy codes, and signoff.
Collaborate with safety, medical, data management and clinical operations to align statistical analysis plans with data collection procedures and forms.
Facilitate and participate in cross functional review of outsourced statistical deliverables such as statistical analysis plans, TLF shells and specifications, SDTM/ADaM datasets, etc.
Provide scientifically rigorous statistical input and review of clinical protocols, draft a statistical analysis plan, interpretation of statistical results and scientific publications.
Work with stakeholders to define business questions, requirements, timelines, objectives, and success criteria to address needs.
Develop strategies to address health authorities’ inquiries pertaining to biostatistics.
Provide programming support across development to support delivery of summarized tabular/graphic analyses for inclusion in publications and external scientific meetings and multi-dimensional nonclinical and clinical data analyses.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

BiostatisticsSAS programmingOncology experienceClinical study designStatistical analysis plansData analysisCDISC standardsClinical database softwareManagement experienceEducational skillsStatistical programmingRegulatory submissionsData interpretationGraphical outputsBudget planningQuality controlTeam oversightAdaptive designBayesian statisticsCollaboration skills

Required

Master or Ph.D. in Statistics/Biostatistics/mathematics with 15+ years of directly relevant experience required.
Good SAS programming skills are required.
Experience required in oncology therapeutic area. Including NDA filing
Prior experience submitting a BLA or NDA filing in multiple assets.
Able to examine relevant data and quickly develop an analysis plan that will answer key business and regulatory questions.
Understanding of clinical or advanced statistics such as regression models, time-to-event analysis, adaptive design, exploratory data analysis methodology in general, K statistics, and the Bayesian statistics.
Experience in working with clinical database software and data structures, especially Medidata RAVE preferred.
Knowledge of and experience with CDISC standards and validation processes required with GCP, ICH and FDA requirements.

Preferred

Management experience in leading team up till 5 people
Collaborative and educational

Company

Kaye/Bassman International

twittertwitter
company-logo
Kaye/Bassman International is a staffing and recruiting company that offers executive search and professional recruitment.

Funding

Current Stage
Growth Stage

Leadership Team

leader-logo
Jeff Kaye
CEO
linkedin
Company data provided by crunchbase
logo

Orion

Your AI Copilot