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RESPONSIBILITIES

As a member of the Biostatistics Center, you will be responsible for: working on sponsored trials with the team, in various roles, the project statistician, the unblinded statistician or the team manager. You will work with the Center Director, Principle Statisticians, Project Managers to determine project-specific requirements, draft Statistical analysis plans and manage pre the project-specific statistical management plans (STAMP). You will be required to ensure that the STAMPs and all related programing adheres to relevant standard operative procedures (SOPs) and Federal guidelines. You will also contribute to the department's growth and development with respect to applications of current statistical programming methodology, data-driven techniques and will support harmonization of company-wide statistical approaches.

Key Responsibilities:

Write, assist or oversee the creation of statistical analysis plans (SAP) and provide input for clinical and non-clinical data analysis
Participate in a highly collaborative environment on multiple projects to ensure that the tasks, per the project STAMP are rendered in a professional manner, based on accurate and appropriate methods, and are on-time and on-budget
Serve as the point of contact and/or track interface between, the stats team and internal and external partners, i.e. DM, PM, IT, etc.
Support the design, analysis and reporting of the statistics team projects, and create: processes, templates, standards, programs and program libraries that retain corporate knowledge and provide the foundation for future efficiencies
Contribute in the development of clinical protocols and CRF documents
Create SAS, R or other macro programs for projects or standards
When directed, research innovative statistical methods for study design and analysis to enhance clinical development strategies for clients
Implement improvements in statistics programming , validation programs and randomization schedules
Work with the Center Director and QA Office to maintain appropriate statistics documentation and SOPs

REQUIREMENTS

This position requires senior level experience in (1) understanding data collection, data base construction, QC/QA and GCP, (2) current concepts and appropriate statistical techniques for analyzing data projects using SAS – with R a plus, (3) multiple therapeutic areas and types of clinical design, - observation trials a plus, (4) understand FDA requirements and guidance as relates to IND/NDA trials, and (5) drafting protocols, statistical analysis plans, and integrated or independent summary reports.

The successful candidate must have experience in coordinating with senior staff, and have good client skills. Strong communication skills are mandatory.

Requirements include: Master's degree or equivalent experience, plus 8 or more years of related technical experience with at least three years of experience working in a clinical research organization or relevant industry.

Excellent communication, organizational, and management skills. Experience with project management tracking systems and budgets required. The individual must also be able to manage and prioritize multiple tasks at any given time.

PREFERENCES

Prior work experience in the CRO space, with the pharmaceutical industry, and/ or academic research teams preferred. Experience directing and managing large teams is highly desired.

TERMS

Full Time

LOCALE

Silver Spring, Maryland

COMPENSATION

Negotiable

HOW TO APPLY

Review full requirements/description and apply online at http://www.s-3.com - see Req. # 1249.

DEADLINE

Open until filled.

POLICY

EOE M/F/D/V

Discussion forums: Opportunity: Statistical Manager (#1249) @ Social & Scientific Systems -- Silver Spring, MD (US)

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