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SAS Programmer,Biostatistician(Dir.),Cli
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SAS Programmer,Biostatistician(Dir.),Clinical Data Manager/Coordinator, LAB System Validation,CRS
Company: TechData Service Company Location: US-PA-PA, New Jersey, DE, CA, MA, MD, IL, GA. .
Salary/Wage: 50,000.00 - 200,000.00 USD /year
Depending on experience Status: Full Time, Temporary/Contract/Project, Employee, Intern .
Job Category: Biotech/R&D/Science Occupations: Pharmaceutical Research .
Relevant Work Experience: 2+ to 5 Years Career Level: Experienced (Non-Manager) .
Industry: Biotechnology/Pharmaceuticals Education Level: Bachelor's Degree .
Job Description
We are recruiting multiple clinical statistical/SAS programmers, Bio-statisticians, Director of Biostatistics–Oncology, Associate Director of Programming, Sr. Clinical Data Manager, Clinical Data Coordinator, Computer (Lab) Systems Validation Analyst, Clinical Research Scientist for clients in PA, New Jersey, DE, CA, MA, MD, IL, GA.
Statistical Programmer (SAS) (May work from Home for some Phase I positions)
Responsible for statistical programming in support (analysis datasets, pooled datasets, listing and tables) of individual phase I-IV clinical trials and project level activities for drug project / indications.
Make certain that study documents and specifications are consistent and comply with company standards by providing input into Study protocol, CRF and Data structures and outputs (listings, tables and figures) for phase I – IV clinical trials and submission activities.
Program according to specifications, analysis datasets, pooled datasets, listings, tables and figures for phase I-IV clinical trials and for SCS and SCE with high quality and within milestones.
Develop programming specifications for analysis datasets, pooled datasets and deliverables in consultation with the statistician.
Support quality control and quality audit of deliverables.
Skills: Ability to coordinate programming work across a clinical study.
Experience in Oncology therapeutic area is a plus
Intermediate to expert knowledge of / experience with SAS software (including SAS macro language)
Good understanding of regulatory requirements relevant to statistical reporting (e.g. GCP, ICH)
Fluent English (oral and written)
Intermediate knowledge of office tools
Education: BA/BS or equivalent experience in mathematics, statistics, computer science, life sciences or related field, with at least 4 years of experience in a programming role supporting clinical trials in the pharmaceutical industry, or MS statistics/computer science with at least 2 years of similar experiences.
Bio-statisticians:
Review protocol, write analysis plans and design data presentations. Must have MS or PhD in statistics and a minimum of 2 years experience in the pharmaceutical, CRO or biotech industry. Candidates must possess good working knowledge of SAS/Base, SAS/Macros, SAS Procedures and Report, SAS Graphics, SAS/Stat and SAS Version 8.2; Able to function in a team setting with good verbal and written skills. Experience with electronic FDA applications, NDA and experience with Items 10 and 11 of the FDA regulation for electronic submissions are big plus.
Sr. Clinical Data Manager
Duties: ***Please identify more senior level candidates for the EDM group***
***PLEASE SUBMIT CANDIDATES WITH INFORM EXPERIENCE***
Responsible for providing timely and prefessional ongoing quality management of clinical trial ata by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards. Review and contribute to the development of trial validation plan related documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data. Review and contribute to the preperation of protocols, CRF's and prepare or review/contribute to operations manuals. Organize / chair data management meetings. Support and assist clinical data managers, clinical data assistants for allocated trials. Work very closely with Contract Research Organizations (CROs) contracted to perform data management functions. Travel when required. All other duties as assigned. Looking for a very high functioning person with the ability to work independently and complete a high volume of work. SAE reconciliation/3rd party reconciliation experience helpful.
Skills: INFORM Education: BA/BS
Clinical Data Coordinator
Review and prepare Case Report Forms and peripheral study data for data entry. Perform data validation using the errorlog and automated query system. Log queries onto the Query Resolution Management System. Handle all DRQ replies which may involve interpretation and decision making as to appropriate course of action. Run reasonability checks. Review and resolve listings of errors/inconsistencies identified by reasonability checks. Reconcile the Serious Adverse Event listings from the Central Safety Serious Adverse Events DB w/ the patient database. Participate in the QC review of study data prior to study release. Assist w/ review and evaluation of protocol against CRF. Report findings to senior staff to assure consistency and accuracy. Assist in the development of data validation specifications. May serve as initial customer contact by answering basic questions from customers. Effectively communicate w/ colleagues and customers to maintain a consistent approach in handling the work.
Computer Systems Validation Analyst
Laboratory Computer Systems Validation - Scope of Work
* Support creation of Periodic Review documents for existing laboratory computerised systems and analytical equipment.
* Create project plans, manage project validation and change control activities, and prepare and report project metrics for the qualification and validation of current and new computer systems and analytical equipment.
* Prepare and review qualification and validation documentation for
current and new computerized systems and analytical equipment
* Assist in the execution of validation protocols
* Maintain computerized system registry
* Manage documentation for current and and new computerized systems
* Track Performance Metrics and Project Status
Sr. CRS (Clinical Research Scientist)
Number of Years Work Experience Required: 2+
***Candidate MUST have Phase I experience.***
- Must be computer literate at a high level and willing to learn new systems
- 2-3 years of prior Phase 1 experience in healthy, normal volunteers required (including writing Phase 1 protocols and monitoring Phase 1 studies)
- Must work well with external customers and be willing to travel
- Must have excellent teaming and communication skills
- Understands and has experience with operational aspects of Phase I studies and participate in activities that ensure quality, consistency, and integration of study data and progress SD deliverables to time cost and quality from Study Delivery Concept through database lock and study close-out activities.
JOB RESPONSIBILITIES:
- Establish and maintain key interactions with major customers (internal/external) and interface with cross-functional departments to ensure quality of SD deliverables.
- Monitor study conduct and progress, proactively identify risk and mitigate issues which may impact study tracking, quality, timelines or budget.
- Lead preparation and delivery of Study documents for example protocol, DMP, SDV plan, confidentiality agreements, clinical study agreements, and clinical trial applications.
- Ensure timely entry and/or update appropriate information into IMPACT and other SD communication tools.
Contact Information
Company: TechData Service Company
Email: recruiting@techdataservice.com
Phone: (267) 234-4774
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Applicant Category: Professional
Requisition Code: Work at home
Two Initials of Recruiter: bw
System Date: 05/01/2008
System Time: 15:42:21
Document Name(40): SAS Programmer,Biostatistician(Dir.),Cli
Source: Philly.com
SearchTerms: "work at home" "work from home"
URL(80): http://jobview.philly.monster.com/getjob.asp?JobID=70533482&JobTitle=SAS+Program
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