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PMV Pharmaceuticals, Inc. · 3 days ago
Director, Biostatistics & Data Analytics
Princeton, NJ
Full-time
Hybrid
Director
5+ years exp
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Hiring Manager
Dana Lombardi
Insider Connection @PMV Pharmaceuticals, Inc.
Responsibilities
Collaborate with the clinical development team in designing clinical trials ensuring that statistical principles are applied appropriately.
Support the clinical development team in global Health Authority interactions as the Biostatistics representative.
Responsible for randomization plans, where applicable.
Collaborate with 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, interpretation of statistical results and scientific publications.
Work with stakeholders to define business questions, requirements, timelines, objectives, and success criteria to address needs. Participate in regularly scheduled meetings that require statistical input.
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 .
Maintain and modify in-house code.
Qualification
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Required
Masters in Statistics/Biostatistics with 5+years of directly relevant experience required
Strong R programming skills are required
Experience required in oncology therapeutic area
Prior experience supporting a BLA or NDA filing and representing biostatistics in interactions with health authorities required
Able to examine relevant data and quickly develop an analysis plan that will answer key business questions
Understanding of clinical or advanced statistics such as regression, time-series forecasting, clustering, decision trees, exploratory data analysis methodology in general, scenario analysis, modeling, optimization, and unstructured data analysis
Experience in working with clinical database software and data structures, especially Medidata RAVE
Knowledge of and experience with CDISC standards and validation processes required
Familiarity with GCP, ICH and FDA requirements required
Strong written and verbal communication skills
Excellent interpersonal skills. Ability to work effectively cross-functionally
Preferred
Experienced in SAS preferred
Benefits
Medical benefits package
Generous PTO policy
Competitive salaries
Employee Stock Purchase Plan
Employee Referral Program
Company
PMV Pharmaceuticals, Inc.
At PMV, we believe that by specifically targeting each mutant p53 we can fundamentally disrupt the course of cancer.
51-200 employees
H1B Sponsorship
PMV Pharmaceuticals, Inc. 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
Trends of Total Sponsorships
2023 (2)
Funding
Current Stage
Public CompanyTotal Funding
$236MKey Investors
Nextech InvestTopspin PartnersOrbiMed
2020-09-24IPO· nasdaq:PMVP
2020-08-03Series D· $70M
2019-11-13Series C· $62M
Leadership Team
David Mack
Co-Founder, President & CEO
Arnold Levine
Co-Founder
Recent News
2024-04-13
2024-03-27
2024-01-19
Company data provided by crunchbase
