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 | ||
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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. |
| 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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