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BIOSTATISTICS POSTINGS

 

Job Title:	Sr Biostatistician
Category:	Exempt
Posting Code:	3027712
Location:	Pembroke Pines, FL
Relocation:	No Relocation Assistant Available
Job Type:	Contract
Shift:	1st
Purpose:	Provide statistical and analytical support for research, clinical trials & post market studies.
Summary of Major Responsibilities:	ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Comply with appropriate regulatory requirements and follow regulatory guidance, use sound scientific/statistical principles and judgment, and serve as a resource of consultation for clinical research and development. Develop and refine objectives, endpoints, and measurements for pre-clinical or clinical studies. Consult with management and appropriate personnel to determine study assumptions for calculating sample sizes and determine the sample sizes, as well as help assess the risk factors to study success (regulatory approval of investigational products). Develop and document protocols, analysis plans, data forms, and procedures for clinical studies. Work with clinical data management personnel to develop specifications for database designs that assure quality, integrity, and timely availability of data. Participate in interacting with outside statistical consultants. Determine optimal approaches to collecting, analyzing, and presenting data for presentations and publications. Perform and interpret interim and final analyses of data in support of regulatory submissions, including writing statistical reports. Perform and interpret ad hoc analyses for the requests made from internal and external sources. Validate statistical programs and prepare appropriate documentations. Interact with and present to management and reviewers at FDA and other regulatory agencies. Interpret results of analyses and defend statistical methods employed, including frequentist and Bayesian paradigms. Stay abreast with new developments in statistical methodology. Conduct statistical research as needs arise. Mentor junior statisticians. Other activities associated with analytical efforts as needed.
Summary of Major Requirements:	QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: Master’s degree in statistics or biostatistics is required. Ph.D. degree in statistics or biostatistics is strongly preferred. A Ph.D. with one to three years, or an M.S. with three to five years, of pharmaceutical and/or medical device industry experience is preferred. Training in Bayesian statistics is highly preferred, although not required. Prior experience with FDA and other regulatory submissions is a plus. OTHER SKILLS and ABILITIES: Experience in SAS programming including SAS/Base, SAS/Macro, SAS/Graph, SAS/Access, and SAS/STAT. Capability of using S-Plus and WinBUGS for Bayesian analyses and simulations. Ability to work with minimum supervision and handle multiple projects simultaneously. Superior interpersonal, written communication, time management, and organizational skills. Experience with personal computer software. Familiarity with Oracle/Clinical is a plus. Knowledge of clinical research methodology, FDA and ICH regulations, and regulatory submission process is essential. Some overnight travel required. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and distance vision. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quite to moderate.

         

Job Title:	SAS Programmer
Category:	Non-Exempt
Posting Code:	3027725
Location:	Weston, FL
Relocation:	No Relocation Assistant Available
Job Type:	Contract
Shift:	1st
Purpose:	Act as the primary programmer supporting development of programming methods and standards.
Summary of Major Responsibilities:	Create and implement programming standards. Design and test SAS/MACRO library and utility programs. Serve as a liaison with Data Management, and IT department regarding SAS license/installation issues. Provide SAS Programming input to CRF design and Statistical Analysis Plan. Mentor and train SAS programmers Support Biostatistician by programming: Statistical Analysis data sets, Tables/Listings/Graphs for statistical and clinical trial reports, Tables/Listings for Annual and other Regulatory reports (foreign, IB). Create Patient Profiles. Develop specification and merge Safety & Efficacy datasets for ISS/ISE. Maintain SAS data analysis file library. Perform Quality Control of SAS programs & Outputs.
Summary of Major Requirements:	Education Necessary: B.S/M.S. in Computer Science, Statistics or related Health Science field Minimum of 7-10 years SAS programming experience, with at least 5 years with clinical trial data. ISS/ISE, NDA experience and understanding of eCTD. General knowledge of FDA regulations and drug development process. Good verbal and written communications skills. Excellent interpersonal and organizational skills. Ability to work independently and within a matrix team environment is required

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