Clinovo · 1 week ago
VP, Biostatistics - Oncology
United States
Full-time
Remote
Director/Executive
$250K/yr - $300K/yr
8+ years expClinovo is a company focused on providing innovative solutions in the biostatistics domain. The Vice President, Biostatistics will serve as the project lead statistician responsible for statistical activities at the study and compound level, including protocol development, study design, and regulatory submissions.
BiotechnologyHealth CareHospitalPersonal Health
Hiring Manager
Adam M.
Responsibilities
Lead the development of statistical sections of clinical study protocols, statistical analysis plans, and conduct the analysis and reporting of clinical trial data
Provide strategic input to optimize trial designs in early-phase dose escalation studies and late-phase registrational studies
Oversee CRO statistical activities and manage contractor statisticians to ensure the timely delivery of high-quality statistical outputs
As the biostatistics representative, proactively collaborate with internal and external team members in the assigned projects, and be accountable for all statistics deliverables
Contribute to the biostatistics vendor evaluation and selection
Provide a thorough review of the required components of regulatory submissions, including appropriate datasets, define files, reviewer's guides, and other relevant documents
Contribute to the development of Biostatistics SOPs and standards
Support study/program-level audit and inspection readiness activities as needed
Develop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug development
Qualification
Required
Strong oncology background
Must have experience acting as a compound lead Biostatistician
Strong communication skills
Experience with Regulatory submissions
Experience with Phase 2 and Phase 3 programs - ideally someone who has experience in Phase 1 through commercial
Minimum of MS required (Ph.D. preferred) in Statistics, Biostatistics, or other related fields
MS with 15+ years (Ph.D. with 8+ years) of overall experience, including at least 12+ years (at least 6+ years for Ph.D.) of experience in drug development in a CRO or pharma/biotech company
Oncology experience is required: familiar with oncology drug development, both early and late stage, including efficacy endpoints, RECIST criteria, common statistical issues and study designs in oncology
Must have hands-on experience with SAS programming in clinical studies
Experience with managing CROs and contractors
Excellent project management skills and proven ability to manage competing priorities
Preferred
PhD strongly preferred
Regulatory NDA/BLA submission experience is strongly preferred
Company
Clinovo
Clinovo provides drug development and solutions.
51-200 employees
H1B Sponsorship
Clinovo has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2015-12-28Angel
2014-01-01Series Unknown
Recent News
Keiretsu
2024-11-04
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