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Job Summary

Company
TechData Service Co
Location
East Hanover, NJ 07936
Industries
Biotechnology/Pharmaceuticals
Job Type
Full Time
Temporary/Contract/Project
Employee
Years of Experience
2+ to 5 Years
Education Level
Bachelor's Degree
Career Level
Experienced (Non-Manager)
Salary
50,000.00 - 160,000.00 USD /year
Pay Depending on Job Type and experience
Job Reference Code
TDS2012

SAS Programmer,Statistician,Oracle Clinical,Clinical Data Manager,Drug Safety,Medical Information,CS

About the Job

TechData is looking for Statistical Programmer, SAS programmers, Biostatistician, Medical Information Specialist, Bioinformatics Analyst, Oracle Clinical Programmer, Clinical Data Manager, Drug Safety Associate(Scientist), Clinical Research Scientists  in  NJ, PA, CA and DE.  Please see below requirements and send your resume to: dan.chen@techdataservice.com TechData offers very competitive pay rate and benefits.



 




Statistical Programmer


Provide statistical programming support and validation and help set specifications of analysis datasets, pooled datasets, statistical tables, summaries, figures and listing for Phase II-IV clinical trials. Employ standardized programs where applicable. Provide input into planning documents such as protocol, validation plan, and report analysis plan. Provide outputs for clinical study reports, integrated summaries and electronic submissions. Help respond to health authority inquiries for submitted dossiers. Establish and maintain sound working relationship and effective communications within biostatistics adn statistical reporting adn clinical research.


1-2 years of Analytical experience. Must have 3-4 years of recent industry SAS experience. Good understanding of clinical trial practices, procedures and methodologies. Good verbal and written communication skills. Good interpersonal and organizational skills. Attention to detail and correctness. Working knowledge of office tools.  


BA/BS or equivalent experience in computer science, amthematics, statistics, life sciences, or related field(s). MS in Statistics a plus. 


 


Data Operator  SAS Programmer (2 Positions)


Work with clinical study reams in the development and activities related to non-statistical analysis for ongoing clinical studies. Plans and establishes approaches for coding programs and implements best practices for program documentation and programs for Data Operations. Interacts with various Project Data Managers, Clinical and Regulatory staff associates supporting Global Clinical Data Management projects. Plans and establishes programs for data transfers and dataset generation, and programs for QC coordination. Must be able to deliver non-statistical related request effectively for department head as needed. Oversees documentation and ensures consistent maintenance of code, logs and output within a regulated environment. Design and develop computer programs that produce tables, listings and derived datasets that summarize results of clinical trials but must ensure accuracy of all results and provide appropriate documentation.


Qualifications: Bachelors Degree or Higher


l  Six years of relevant SAS programming in a CRO or Pharmaceutical organization.


l  Good problem solving skills, attention to detail, good verbal and written communication skills.


l  SAS systems experience includes Base SAS, SAS/FSP, SAS/AF, SCL, Macro Facility, SAS/Graph, SAS/Assist and SAS/Insight within a UNIX operating system.


l  Preferred Database systems experience: Oracle, Clintrial and EDC (Inform).


 


 


Data Management SAS Programmer (1 Position)


Perform SAS programming to provide data review listings/reports to support Data Management activities.


Develop macro programs for use by Data management in data cleaning process.


Qualifications:


5 years experience in SAS programming, knowledge of data management process, good understanding of data cleaning process.


 



 


Biostatistician (2 Position)


Looking for a trained statistician (master degree in stat or related field is a minimum)INDUSTRY EXPERIENCE IS A MUST
This is not the Same order/manager as 403631- YOU MAY SUBMIT THE SAME CANDIDATES
 


experience in SAS programming
Experience in Statistical Analysis Plan development
Experience in Analysis Planning
Ability to implement analysis plan in SAS
 


at least a Master's degree in biostat or related field


 



 


Medical Information Specialist


Responds to all on-label and off-label customer inquires for all company marketed and investigational agents received via phone, fax or e-mail.
·Utilizes appropriate information and resources to respond to medical information inquiries, documents the inquiry and the response in departmental database
·Processes and reconciles adverse events for all company marketed products.
·Assists in development of standard and customized responses to customers.
·Escalate calls/inquiries to second-line pharmacist when required.
·Through regular review of customer contact data, alerts management and Therapeutic Teams of emerging trends or issues.
·Present product data to our customers or vendors
·Candidate MUST posses a Pharm.D or Rph degree
·Healthcare professional with 1-2 years of Drug/Medical Information experience.
·Excellent communications, (both verbal and written) skills and computer skills.
·Virology experience required. Candidate must demonstrate good understanding of the HIV market place.


 


 



Bioinformatics Analyst


MS, Ph.D. or equivalent experience in computer science or engineering with at least 2 years work experience at a pharmaceutical or biotech company. 


The successful candidate will have recent experience interacting with Biologists or Chemists to develop and support scientific applications. 


Excellent business analysis skills and demonstrated ability to work as part of a development team are essential.


Recent J2EE, Oracle and XML experience with working knowledge of the full software development lifecycle is desired.  Programming and web design in bioinformatics with computational methods for text-mining and knowledge engineering a plus.


Excellent communication skills are essential. 


The individual will work in close partnership with laboratory scientists and IS/IT professionals to define and deliver informatics projects of benefit to the drug discovery and development process.        


 


                                                  








Oracle Clinical Programmer








OC/Data Management


Complete Description:
Applicant will work within Database Administration with Ad Hoc SAS Programmers, Integrated Review Administrator, OC DBA/Database. Manager and CRF designer to meet the needs of various customers. Customers include Clinical, Programming, Data Management and medical. Applicant will be responsible for Ad Hoc SQL Programming, OC procedure programming and OC study Database Build and Maintenance. Position reports to Manager, Database Administration. Responsibilities for this position include Programming in PL/SQL and or SQL for ad hoc reports (E.g. metric reports from the backend OC tables). Working with the Integrated Review administrator to deploy Ad Hoc SQL reports/SQL code to users via integrated review. Building and designing clinical studies in Oracle Clinical (OC) in concert with Data Managers. Responsible for the documentation, development and maintenance of the OC Global Library according to agreed upon standards. Providing assistance to Data Managers in ensuring that CRFs are compatibly designed with OC standards. Interaction with the SAS. Programming department in standardization of SAS Data Structures. Specific responsibilities: OC study planning, design and standardization. Maintenance of OC and TMS administrative reference code lists. Creation and documentation of DCMs, DCIs and workbooks for clinical studies. Creation and programming of OC validation and derivation procedures including documentation and testing plan. Global Library maintenance (Questions, Question groups, DCMs and DVGs). Interacting with external vendors concerning external data into OC. External data loads, and trouble shooting data loads. OC lab setup including reference ranges, panic flags, unit conversions and Normlab2. Maintenance and upkeep of study view descriptions and study view templates including extended attributes.

Building ad hoc reports in integrated review; Training and mentoring in IR to be provided Applicant will be expected to contribute in refining current Database Administration process as well as revamping and develop old/new processes to increase efficiency. Minimum qulaificaltions including prior experience and knowledge required in order to perform this job include Five or more years experience in Oracle Clinical, with at least two years spent in a database programming capacity. In depth experience with Oracle Clinical database design, PL/SQL. Good organizational and project/time management skills. Team player that can interact successfully with the SAS Programming department and data management within a trial/project. Team player that can interact successfully with the SAS Programmers and the clinical department. Minimum training/education: Degree in life sciences, MIS, pharmacy or nursing; advanced degree desirable. Formal or on the job training in clinical trial methodology and Good Clinical Practice (GCP). Ability to listen and understand the customer's needs

Additional Desirable Qualifications necessary to successfully perform this position: Oracle Clinical/TMS validation experience. Familiarity and working knowledge of Oracle Clinical/TMS underlying database tables. Knowledge and experience in Oracle Clinical add-ons such as Integrated Review and or Oracle Discover and query tools. Good interpersonal skills. Exhibits professionalism and communicated effectively. Capable of handling multiple projects and demonstrates ability to set priorities. Flexible and dependable. Reporting relationship for this position: The Oracle Clinical Programmer/ Database Manager reports to the Director Of data Managment


 


 



Clinical Data Manager II 


Responsible for providing timely and prefessional ongoing quality management of clinical trial data 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. **THIS IS THE SAME MANAGER/DEPT AS 399551 - PLEASE DO NOT SEND THE SAME CANDIDATES***
Work very closely with Contract Research Organizations (CROs) contracted to perform data management functions. Travel when required. All other duties as assigned.
 


Significant industry experience required 


BA/BS 


 



 


Clinical Research Scientist


The incumbent will either assist or act as the Local Trial Leader at a level commensurate with experience in the implementation of Phase II-IV clinical studies in the US Infectious Disease and Transplant Immunology area. Key responsibilities will include interacting with a regionally based field monitoring group and managing clinical investigative sites in the day-to-day activities of clinical trials, preparation of required study documents (including regulatory documents), and assuring that data is collected according to Standard Operating Procedures. The incumbent will also interact with other line units in support of clinical trials and ensure that project timelines are met by closely monitoring study activities and resources. Additionally, the CRS may also assist in the preparation of Clinical Trial Protocols, Clinical Trial Study Reports, publications/manuscripts and may also serve on the clinical trial team. Some travel may be required but is typically less than 10%


The position will be filled at a level commensurate with experience, however, the requirements include a minimum of a  minimum of five years relevant experience in a clinical research/drug development environment is required for a Sr. CRS position. A background in pharmaceutical industry research in the therapeutic area is preferred, but is not required. Effective oral and written communication skills are a must. The demonstrated ability to independently write Clinical Trial Protocols and Clinical Trial Reports is required for a senior level position. The ability to work both independently and collaboratively on Project teams and to recognize safety and efficacy data trends is essential. Knowledge and experience of clinical trial design, analysis, and reporting (for senior positions) is also necessary. The Sr. CRS should be familiar with all aspects of the drug development process and have knowledge of the medical, scientific and clinical research techniques of the assigned area. Working knowledge of GCP and local regulatory requirements is desired


BSN or RN, BA or BS in a scientific discipline, or a pharmacy degree (or equivalent), and at least 2 years of clinical research experience in a pharmaceutical environment


 



















Job Title:


Clinical Safety Scientist III 


  


Duties:


Manager would like to see candidates with previous experience, including former Consumer Health employees and/or contractors.

The Clinical Safety Scientist is responsible for performing global safety activities to ensure compliance with international regulatory requirements. The Clinical Safety Scientist will perform the medical and regulatory evaluation of spontaneous marketed adverse event reports and serious adverse event reports (SAEs) from clinical trials. The Clinical Safety Scientist will write the medical case narratives and provide the coding of adverse event terminology and other medical information in accordance with standardized dictionaries for all adverse event reports. The Clinical Safety Scientist will assess the labeling for event terms against the product’s US local product labeling for regulatory status and for local/international expediting criteria.
 


  


Skills:


Understanding of clinical trial methodogy, adverse events reporting standards, medical terminology and FDA regualtions. Computer literacy, familiarity with WIndows 98 and environment and Oracle database preferred. Excellent communication, interpersonal, organizational, and workload planning skills.
 


  


Education:


RN or RPh ONLY 


 


 

 
 

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TechData Service Co