SAS Programmer,Biostatistician,Clinical Data Manager,Epedemiology,Clinical Research Sci.,Coding Spec

TechData is recruiting multiple clinical statistical/SAS programmers as Contractor or Permanent, statisticians as TA biostat/Principal/sr. Principal biostat/Manager, Sr. Clinical Data Manager/Perm ot contract, Clinical Research Scientist(Data Cleaner), Clinical Coding Specialist, Clinical Research Document Specialist, Sr. Manager for PK Modeling in Clinical Research/Development, Clinical Safety Scientist for clients in NJ, PA, DE, CA, MA. Send resumes to: recruiting@techdataservice.com or dan.chen@techdataservice.com Statistical/SAS programmers (Contract or Permanent):Duties: 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. Establish and maintain sound working relationship and effective communications within biostatistics and statistical reporting and clinical research. Skills: 2-3 years of Analytical experience. Intermediate SAS programming skills, with 2-5 years experience in a medical setting, preferably working with clinical trial data. Good understanding of clinical trial practices, procedures and methodologies. Good verbal and written communication skills. Attention to detail and correctness. Education: BA/BS or equivalent experience in computer science, mathematics, statistics, life sciences, or related field(s). MS in Statistics a plus. Biostatisticians (Contract or Perm. TA Biostat): 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. Principal/Manager/Expert statistician (Permanent)Applies extensive biostatistics expertise. Full knowledge of related disciplines. Solves problems which require regular use of ingenuity and creativity. Work is performed without appreciable direction. Considerable latitude in setting objectives on assignments. Work reviewed from long-term perspective. Guides major programs in project leader role. Errors would thwart major objectives. Prime technical contact on contracts and projects. Works with senior internal and/or external personnel on significant biostatistics matters. Typically requires a Master?s Degree in Statistics with at least 6 years of related experience or Ph.D. in Statistics with at least 2 years of experience. To be considered for this level, demonstrated proficiency in the following skills and responsibilities are required: With minimal supervision, apply state of the art statistical/programming and/or PK/PD modeling in the preparation of CSRs, manuscripts, ISSs and ISEs that meet world-wide health authority and medical community standards, and participate in preparation of protocols and CDPs.Typically requires a Masters Degree in Statistics with at least 6 years of related experience or Ph.D. in Statistics with at least 2 years of experience. To be considered for this level, demonstrated proficiency in the following skills and responsibilities are required: With minimal supervision, apply state of the art statistical/programming and/or PK/PD modeling in the preparation of CSRs, manuscripts, ISSs and ISEs that meet world-wide health authority and medical community standards, and participate in preparation of protocols and CDPs.Sr. Clinical Data Manager (Contract or Permanent): Job Description The incumbent will be responsible for data management functions and/or team within the AI/GI therapeutic area. Candidate will also be responsible for leading/participating on teams in support of project goals/objectives; protocol review, supervising CRF development, monitoring database design, supervising data management activities of CROs or in-house, as applicable. Other responsibilities include: Query generation and resolution process Supervising AE and medication coding SAE reconciliation and patient profile review Participating in development of DM SOPs Supervising direct reports and providing performance evaluations as applicableJob Qualifications Degree in associated functional discipline or college/RN required or commensurate experience in Data Management. Masters degree advantageous. CDM certification desirable. At least 4 years experience in the pharmaceutical industry required, including line management. Knowledge of Clintrial or database system. Computer proficiency and understanding of computer terminology. Knowledge of medical terminology. Clinical Research Scientist (Data Review/Cleaning) Duties: The team is looking for highly motivated and pleasant individuals with previous experience in a global pharma company or those with experience in conducting a global study. We have a strong preference for those with a strong scientific or clinical background (i.e., oncology nurse, pharmacists, etc) and those with prior data management experience. This experience will be of help in the review of patient data and involvement with data cleaning activities. Furthermore, we are also very open to individuals with CRA experience and those who have been involved in study closure activities and/or preparation for health authority submission. Scope of work Primary work will be with clinical data review on patient profiles (PP) for GIST and CML Review of usual safety parameters and appropriate cross-checks Review of efficacy results according to RECIST Guidelines Version 2 • Assist CTH on follow up on audit findings • Biomarkers database reconciliation • Biomarkers sample tracking • Communication with Data Management • Contribute to data assembly for senior management, DMC, Steering committee • Contribution to assembly of various documents for regulatory submission (SCE, SCS, CO etc) • Contribution to CSR completion (body and appendices) • Contribution to periodic safety review • Contribution to PK reconciliation and sample tracking • Coordination of drug destruction • Coordination of extension roll-over • CRA communication • ECG management • Involvement in TMF updates • Potential involvement in third party database transfer • Materials retrieval for sites that are closing (including third party materials as well) • Narratives - data provision, coordination of narratives review and QC • QC of various documents for regulatory submission • Regulatory approval trackers • Retrieval and clinical review of patient profiles • Review of imaging data and contribution to imaging reconciliations (CT, MRI, PET) • Review of patient using I-review • Review of statistical outputs • SAE reconciliation • Tracking and identifying protocol deviations • Tracking of essential documents • Support of Tasigna project level activities if needed (flexibility required, if support on other studies is needed) Skills: Must have a scientific or clinical background (esp. oncology nurse etc.); or data management background who worked in oncology at least 2 years and knows to clean efficacy and safety related data as well Education: BA/BS or advanced degree Nurse or RPh would be ideal. Clinical Database Designer/SAS ProgrammerWork Location - New JerseyCompany Description Develop and maintain trial specific database applications, including: eCRFs, validations programming, monitoring reports, database specifications and programming of protocol deviations in support of in-house and outsourced trials for Phase I-IV. Ensure quality and time management of deliverables.Minimum requirementsBA / BS degree in Computer Science, Mathematics, Life Science, Medical Informatics or equivalent degree. Ideally 3 – 5 years of experience in clinical programming, set-up of clinical databases and CRF Design, gained in pharmaceutical industry or CRO as well as the following: Strong knowledge of database support: Oracle (SQL or PL/SQL) or equivalent clinical database management system. Strong knowledge of reporting support: SAS, SQL or other equivalent ad-hoc query and reporting tools. Strong understanding of clinical database management systems and/or relational databases as applied to clinical trials. Ability to analyze the impact of changes to clinical standards, with minimal supervision. Ability to multi-task. Ability to be able to switch between different tools for database design, reporting and management. Strong understanding of ICH and Health Authority guidelines and regulations as they pertain to clinical database management, clinical data reporting and computer systems. Strong attention to all of the following: detail, quality, timelines and customer focus. Ability to work to deadlines independently. Strong communications skills required in order to be able to work with a wide variety of global customers both face-to-face and via phone or e-mail.Required years of experience Three - Five YearsSenior Manager, PK Modeling (Permanent) Clinical Development/ResearchThe incumbent will be responsible for, but not limited to the following: · Implementation of M&S strategies, including design and analysis of population) PK and PK/PD studies, with the support of group members and through outsourcing. · Conducting PK and PK/PD data analysis, using methods across the spectrum from noncompartmental to population approaches. · Assist in compilation of PK and PK/PD analysis plans, datasets and reports in accordance with departmental SOPs. · Interact with clinical, statistics and data management functions. · Represent at major scientific and medical meetings. · To maintain knowledge of PK, PK/PD and modelling and simulation approaches.Epidemiology Programmer Analyst:Job Description: Collaborate with research teams in conducting epidemiological studies utilizing large national/international cross-sectional and longitudinal healthcare databases. Provide statistical programming, database management and systems analysis support and consultation for epidemiologic database research projects relating to disease natural history, burden of illness and drug safety. Investigate, evaluate and apply new methods, technologies and tools for efficient accessing, processing, management, analysis and communication of observational research data. Develop, implement and maintain standards for computer program development and validation, and for data storage, quality and reporting.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