Location: Mahwah, NJ, USA
Closing Date: 11 Nov 16
Type: Full Time
Salary (£): Competitive
This is a full time/permanent office based position in Mahwah, NJ. Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
Provide experienced Statistical insight to Clinical Development Plans (CDP), Clinical Study Protocols (CSP) and Clinical Study Reports (CSR) across the Innovative and Approved products/Branded generic portfolio globally. Responsibilities: Analysis and interpretation of data for Innovative portfolio of small molecules and Biologic projects (Phases 1 to 4). Analysis and interpretation of data for Regulatory and Market access projects with Approved/Branded generic portfolio, including Devices. Write and review Statistical Analysis Plan (SAP). Review Statistical Analysis outputs. Work efficiently with Mumbai-based Programming colleagues, study data management group and external providers. High-quality inputs into the study design. Demonstrate progressive thinking by suggesting alternative designs and innovative/novel analyses methods Requirements: Minimum MSc level, PhD preferred Technical competence: • Statistics: Multivariate methods (MLR, MANOVA, …), non-parametric methods, categorical analysis, exploratory and confirmatory factor analysis • Research methodology • Computing platforms • Statistical software experience Minimum of 5 years’ experience in a similar senior role handling design and analysis of Phase 1 to 4 clinical studies, Responsibility for design and analysis plans for multiple studies using innovative analyses methods. Direct exposure to mature market Regulator (FDA, EMA, …) desirable Experience managing contractor/CRO staff desirable. Demonstrated competence in statistical discipline (ie. Frequentist and Bayesian)
Wilmington, North Carolina, USA
2520 Independence Blvd, Suite 202, Wilmington, NC 28412, USA
|Tel:||+1 910 338 4760|
|Fax:||+1 888 301 2627|
|Website:||Visit Our Web Site|
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