SAS Programmer/Biostatistician(Director)/Clinical Data manager,Oracle Clinical/CRA/CRS/Coding

We are seeking clinical SAS programmers/Statistical programmer(Contract or Permanent), biostatisticians (contract/ permanent including director), clinical research associates (or scientists), Clinical Data manager, Oracle Clinical Programmer, Clinical Research Manager, clinical data management programmer, Coding Specialist for pharmaceutical clients in PA, NJ, NC, DE, MD, CA, CT, MA. See the requirement for each position below and send your resume with confidence to: recruiting@techdataservice.com Clinical SAS Programmer I: Develop, review, and/or perform validation of generic SAS macros; Write clinical SAS programs/macros to support Regulatory Submissions (eNDAs); Use SAS/Base, Macro, Procedures, SQL, Graph, ODS to develop analysis datasets, generate listings, summaries, and figures; Familiar with the validation (QC) process, FDA update and ISS. Must have 3+ years SAS programming experience in pharmaceutical, CRO or biotech companies.Statistical Programmer II: Experience in both SAS/Graph and S-Plus in the clinical trials area and have experience using the macro language to develop standard tables and or graphs. Experience in both SAS/Graph and S-Plus in the clinical trials area and have experience using the macro language to develop standard tables and or graphs. Knowledge of SAS Graph, Base SAS, and clinical data. Requirements: Four-year degree in scientific discipline with clinical trials experience. Knowledge of current statistical programming techniques and 6 years SAS software systems experience. Programming experience using clinical trials data for 6-10 years required. Advanced degree may substitute for up to 2 years experience. Knowledge of multiple hardware platforms and a variety of software. Biostatisticians: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.Direcor of Biostatistics in Northern NJJob Description Assume accountability for statistical support for clinical trials/clinical development plans within commercial operations, across multiple therapeutic areas including CNS, GI, Oncology and Institutional Care. • Take an enterprise-wide perspective and influence the proper use of statistics throughout commercial operation; contribute to the development of Biometrics SOPs, standards and guidelines. • Work with the clinical, marketing, project management, and data manager teams on strategic designs of studies; development, review and approval of clinical study protocols; review and approval of CRF, edit check specification, data management plan, and final database validation; author or review and approval of statistical analysis plans and final study report; performance of statistical analysis. • Work with the internal / CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs. • Work with regulatory and Medical Affairs clinicians on submission strategies and lead statistical activities on FDA submissions. • Support publication and other marketing strategies.Job Qualifications • Minimum of a Masters degree in Biostatistics (PhD highly preferred) or related discipline with at least 8 years of relevant experience in the pharmaceutical industry/CRO environment. • Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process. • Experience with CRO overseeing and FDA submission highly desirable. • Excellent technical writing and verbal communication skills. • Strong teamwork ability/commitment and individual initiative. • Strong organizational skills with ability to effectively manage multiple studies.3 Clinical Data Manager (Northern NJ and DE)Duties: 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. Work very closely with Contract Research Organizations (CROs) contracted to perform data management functions. Travel when required. All other duties as assigned. Skills: Pharma industry experience Education: BA/BS Clinical Research Associate (Scientist):BS in biology or related field and 1+ years hands-on experience in clinical trials. Demonstrates computer proficiency. Excellent organization and time management skills. Excellent oral and written communication skills. Knowledge of the clinical study process, GCP/ICH guidelines. Familiarity with medical terminology. Incumbent will assist the clinical study team in the execution of operational activities for clinical studies up to and including: · Interface between regional monitors and investigator sites· Manages day-to-day interactions with study sites· Review Informed Consent Forms· Prepares study start-up documents including investigator study files, enrollment logs, etc. Identifies study-related issues and provides recommendations for resolution· Reviews, maintains, and archives study administrative and data management files· Review regulatory documents.Clinical data management programmerHave some SAS experience, prefer 2+ years experience in clintrial, oracle clinical, or INFORM in pharmaceutical industries.Clinical Data Manager Responsible for providing timely and professional 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 preparation 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. Clinical Research Manager: Responsible for implementing and completing a registration program for Phase II. Prepares and reviews Clinical Protocol Summaries and Clinical Trial Protocols. Prepares/reviews Clinical Trial reports and Summaries. Provides clinical research and operational expertise in the development of overall strategy and objectives of clinical plan. Preparation and implementation of project specific training programs and training materials for internal and external staff. Participates in cross-functional teams in support of continuous improvement and other management objectives. Main contact for operational execution/development of program. Leads and develops CRS/Sr.CRs with execution of trials. Provides weekly/monthly reports regarding clinical study budgets, timelines, patient updates. Makes the recommendations regarding monitoring safety, eligibility, enrollment and data consistency. Responsible for compiling of FDA-IND updates, Investigator Brochure updates, and briefing books for US and regulatory authority meetingsRequirements: University degree in Biological Sciences/Nursing degree/Pharmacy degree Demonstrated ability to write protocols and Clinical Trial Reports independently. Medical-scientific writing skills Ability to recognize safety and efficacy data trends independently. Knowledge of clinical trial design, statistics and pharmacokinetics Familiar with all aspects of the drug development process Knowledge of the medical, scientific and clinical research techniques of the assigned area Knowledge of GCP and local regulatory requirements Effective oral and written communication skills 5 years of experience in clinical research environmentOracle Clinical Programmer / Database Manager1. Responsibilities of this position include but not limited to:· Design, build, and maintain Clinical Studies in Oracle Clinical (OC) including DCMs, DCIs and workbooks.· Load Batch Data into OC and have external data load expertise, including the ability to work with external vendors and specifications.· Create and maintain OC Validation and Derivation procedures.· Program ad hoc reports using SQL and/or SAS. Training will be provided to deploy these reports via IReview.· Create and maintain Study View Definitions, Custom Views and Templates including Extended Attributes. · Serve as OC Global Librarian: develop and maintain Global Library (Questions, Question Groups, DCMs, DVGs, etc)· Maintain OC Lab set-up, including Reference Ranges, Panic Flags, Unit Conversions and NormLab2.· Maintenance of OC and TMS Administrative Reference Code Lists· Work with DMs to ensure CRFs are designed according to Global Library and CDISC Standards· Interact with SAS Stat Programming Group concerning standardization of SAS data structures, etc.· Develop, enhance and maintain documentation and processes related to Clinical Study set-up, Batch Data Load Process, Global Library, and Validation and Derivation procedures (including Testing Plans)· Five + years experience with Oracle Clinical with at least the last 3 years as a database programmer.· In-depth Oracle Clinical database design knowledge and experience.· Proficiency in SQL and PL/SQL· Familiarity with clinical research practices, medical terminology, and statistical analysis· Experience using a clinical data reporting tool, such as Integrated Review.Job Title: Clinical Coding Specialist Duties: Ensure consistency of coding across and within projects with particular emphasis on adverse events . Contribute to and review Validation and Planning (eVAP) coding section. Input into User Acceptance Testing (UAT) specifically for coded term fields. Consult with International Clinical Team Leaders, Medical Advisors, CDMs, CDAs, ICRO Field Monitors, Investigators and Statisticians to resolve coding problems and queries. Manually encode medical and therapy terms not automatically encoded by the data management system. Generate requests for new Medical and Therapy terms and changes to existing terms, and ensure appropriate changes are made to the dictionaries as agreed. Develop and maintain excellent knowledge of medical and therapy terms using appropriate information tools, e.g. electronic dictionaries, internet etc. Provide assistance if required for Contract Research Organisations (CROs). Provide medical terminology glossaries for review by project CPEs for Clinical Pharmacology trials. Participate in initiatives to improve the coding processes and systems. Skills: Typically 2 or more years experience in drug development, including 1 or more years in the discipline of data managemen. Understanding of clinical trial methodology, GCP and medical terminology. Understanding of dictionary philosophy specifically with regard to MedDRA and WHODRL. Good computer skills Attention to detail Good organisational and planning skills Good interpersonal and communication skills and the ability to operate effectively in an international envi-ronment Good understanding of physiology, pharmacology, clini-cal study objectives and the drug development process. Good problem solving skills. Ability to work as part of a team and without close su-pervision. Ability to work under pressure and meet timelines Education: Degree in life sciences, pharmacy, nursing (e.g. SRN in UK) or equivalent relevant experience. Job Title: Clinical Safety Scientist Duties: ***NO MDs DOMESTIC OR FOREIGN*** Responsible for taking calls from Healthcare professionals, probing callers for complete case information and writing reports to send into Drug Safety. Working in conjunction with Medical Information. Will be given training in Risk Management for certain products. B.S. or higher degree in NURsing and Pharmacy. Preferred: 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. Interviews will take place in Bldg 419, but worker will physically work in Bldg 122 (across Ridgedale from main campus) 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, RPh, PharmD ONLY