Research Fellow - Bio-statistician, Clinical Research (will consider remote working) at Perrigo
Posted in General Business 16 days ago.
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Location: Grand Rapids, MichiganJob Description:
Research and Development/Analytical and Formulary • Allegan, Michigan | Bronx, New York | Minneapolis, Minnesota
PLEASE NOTE - This role may work at any Perrigo location in the US. Candidates who meet all qualifications listed below may be considered for remote working assignments if they have demonstrated a capability to work independently in the past and are willing to travel with some regularity to the Bronx and/or West Michigan.
- The incumbent will independently lead and manage the statistical needs of the global clinical program primarily covering human bioequivalence studies related to clinical end-point and pharmacokinetic end point studies including dermal safety trials, vasoconstrictor trials, and pharmacodynamic trials.
- Application of statistical test for clinical bioequivalence, superiority, and non-inferiority studies.
- Expertise in statistical software includes SAS, WINNONLIN, PASS, and nQuery are required. SAS-JMP, and MINITAB or equivalent is a plus.
- Responsibilities entail application of statistical methodologies including but not limited to:
- Regression analysis - univariate and multivariate linear regression, non-linear regression including binomial, logistic, and Poisson, linear models (generalized and hierarchical - including mixed effects, random effects, and fixed effects.).
- Categorical data analysis, non-parametric statistical methods including Survival Analysis (Wilcoxon signed rank test, Mann-Whitney test, randomization test, Kruskal Wallis test, Friedman's test, Kolmogorov test, contingency tables, Chi-square and Fisher Exact Test, ANOVA, ANCOVA, etc.)
- Design of experiments for fully randomized designs as well as more complex designs involving limits to randomization, optimization techniques (I-optimal, D-optimal, and alias optimal designs), familiarity with design diagnostics (statistical power, reductions in factor correlations, variance inflation factors).
- Prior experience or exposure to adaptive clinical design and group sequential designs, including futility analysis will be given additional consideration.
- Good understanding of bio-informatics, Bayesian inference, causal inference, longitudinal studies, canonical correlations, cluster analysis, dimensional data analysis, sequential methods, and survival analysis.
- Simulation modeling including bootstrapping of results to estimate parameters, MonteCarlo simulations, and advanced modeling techniques that include k-fold cross-validation to mitigate over-fitting.
- Contribute to the development of SAP, DMP, develop table figures and listings, statistical programs, clinical study reports.
- Ensure that preclinical and clinical study data is created in a usable format for dissemination, catalogued and managed efficiently according to Good Clinical Research Practices.
- Demonstrate statistical expertise in supporting clinical studies include descriptive statistics, sample / size estimation, power calculation, estimation of treatment effects, outlier analysis, randomization schedules.
- Exhibit good understanding of regulatory requirements for statistical analysis of clinical studies per US FDA, EMEA, and MHRA. These include products that are filed for US FDA approval using NDA, ANDA, 505(b)(2), IDE, and BLA pathways.
- Draft, review, and approve statistical sections of clinical study protocols and reports, including SOPs, expert reports, Statistical Analysis Plans, white-papers, and dossiers for regulatory support and submission.
- Participate as a scientific lead on due diligences related to in-house and partnership products, in-licensing and / or acquisition of product and related assets (dossiers, technology, etc.)
- Training existing staff in Biopharmaceutics and Global Clinical groups on general and applied statistical techniques, including simulations and bootstrapping.
- Experience in Dermal, Women's Health, and/or Ophthalmology studies is a plus.
- Prior experience should include statistical programming and bio-statistical evaluation of data generated from studies conducted on pharmaceutical dosage forms such solid and liquid oral products, topical products, transdermal patches, ophthalmic, metered-dose inhalers, parenteral dosage forms, and drug-device combinations.
- In order to ensure that responsibility and accountability of the committed deliverables are met to support multiple projects across different Perrigo sites (domestic and international), the flexibility of traveling on business to about 15% of approved work hours is expected.
- At a minimum, candidates should have a MS and 5 years of relevant industry experience OR a PhD and relevant industrial experience (which may be gained through consulting for relevant Pharmaceutical clients during their Post Doc) to be considered for this role.
Equal Employment Opportunity/M/F/disability/protected veteran status.