Planet Pharma ยท 15 hours ago
Clinical Application Specialist II
United States
Full-time
Remote
Mid Level
$47/hr - $57/hr
3+ years expPlanet Pharma is seeking a Clinical Application Specialist II to support the Global Epidemiology department within Clinical Sciences. This role involves conducting pharmacoepidemiologic studies, contributing to regulatory submissions, and performing literature reviews while maintaining scientific rigor.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Conduct literature reviews and data landscaping, including evaluating, synthesizing, and communicating epidemiology literature in both written and presentation formats
Lead and contribute to real-world evidence (RWE) generation, including evidence gap identification, study conceptualization and design, development of protocols and statistical analysis plans, collaboration with analytic teams for high-quality study execution, rigorous interpretation of results, as well as synthesis and dissemination of findings through internal decision materials, cross-functional forums, and external scientific communications
Contribute to product safety and benefit-risk evaluations, including epidemiological safety assessments, development of safety-related analyses, and contribution to risk management plans, benefit-risk assessments, and regulatory safety deliverables
Qualification
Required
PhD with experience in the field of epidemiology, outcomes research, or related discipline
Excellent understanding of epidemiologic data sources, methods, and study design; and a demonstrated ability to apply them to address program needs
Knowledge of public and private real-world data sources including large observational databases
Experience in conducting comprehensive literature reviews to synthesize current research findings and identify gaps in existing knowledge. This includes proficiency in using databases such as PubMed, Embase, and Cochrane Library, as well as expertise in assessing the quality and relevance of scientific articles
Experience with disease state epidemiology (eg, population sizing) globally and regionally using short-term studies/analyses
Understanding of methods for adverse event collection and evaluation, signal detection, and signal validation. Familiar with quality assurance, legal and regulatory functions, database functionalities, and management processes. Knowledgeable of U.S. and international safety regulations and current regulatory safety review processes
Demonstrated experience in managing large studies or projects
Excellent oral and written communication skills. Ability to clearly communicate epidemiology concepts, both verbally and in writing, to diverse audiences. Able to articulate study rationale, design, and expected impact on supported programs
Ability to generate tables, listings, and graphs for compound projects. Responsible for the validation and quality assurance of any output produced
Experience Level = 3-5 Years
Preferred
Prefer candidate with experience in SAS, R, Aetion, or other data analytic platform
Preference given to individuals with industry experience
Experience in the Neuroscience therapeutic area ideal but not required
Prefer candidate with clinical experience
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma 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
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
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