*PLS SEND RESUMES TO [email protected] <[email protected]> OR CALL ME AT 732-393-1313 EXTN 109*
*IN-PERSON IS MUST FOR ALL POSITIONS* *Position#1* Role : Statistical SAS Programmer- Neuroscience Location :Woodcliff Lake NJ Duration ; Long Rate ; Best To support the Biostatistics team by carrying out and overseeing programming activities of statistical programmers and external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment. Main duties/responsibilities: 1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets. 2. Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management. Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents. 3. Managing and developing team, maintaining standards for programming activities, and guiding/coaching Statistical programmers. 4. Working independently to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process. * Responsibilities weighting may change significantly based on the incumbent and their assigned areas of responsibility. *Qualifications and education required: * * Minimum of Bachelor's degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred. *Experience required: * * Minimum 5 years experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment. 7+ years programming experience and FDA submission experience preferred. * Some project experience in a pharmaceutical/CRO programming environment or demonstrated leadership in a clinical pharmaceutical/CRO environment. *Skills and aptitude required: * * Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. * Experience in CDISC data standards, e.g. SDTM and ADaM * Proven experience with Unix and Windows operating systems. * Understanding of the software development life cycle. * Understanding of FDA guidelines. * Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. * Applies good judgment and demonstrates initiative to resolve issues. * Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as *Position#2* Role : Statistical SAS Programmer- Oncology PCU Location : Woodcliff Lake NJ Rate : Best Duration : Long Main purpose of the job: To support the Biostatistics team by carrying out and overseeing programming activities of statistical programmers and external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment. Main duties/responsibilities: 1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets. 2. Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management. Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents. Determining and researching SAS software upgrades and related systems and addressing maintenance issues. 3. Managing and developing team, maintaining standards for programming activities, and guiding/coaching Statistical programmers. 4. Working independently to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process. * Responsibilities weighting may change significantly based on the incumbent and their assigned areas of responsibility. *Position#3* Role : Statistical Programmer Location : Hopewell NJ Duration : Long Rate : Best The Clinical SAS Designer/Programmer creates SAS programs and mappings in support of the companies CDSIC based clinical data standards according to guidelines and industry CDSIC best practices. This programmer will create, document, validate, process, and maintain statistical programs and macros that generate analysis datasets, tables and graphics with high quality per agreed timelines. Assist them in overseeing the daily tasks associated with clinical programming and subsequent analyses to ensure project deliverables are created per agreed timelines and to high quality standards. * Ensure SAS programs adhere to guidelines, and specifications * Ensure SAS program output matches the requirements of the Specifications * Design and/or review analysis (ADaM) data structures * Create analysis (ADaM) datasets * Execute analyses specified in the Statistical Analysis Plan (SAP) or Report and Analysis Plan (RAP) under the guidance of the project statistician * Take instructions and perform tasks as necessary as directed by reporting manager * Ensure specifications and documentation are correct and complete * Work with other team members to ensure outputs are correct and complete * Organize, plan, and prioritize work to accomplish project objectives * Analyze information and evaluate results to choose the best solution and solve problems. * Minimum of a Bachelor's degree * Minimum 6 years SAS programming experience/clinical data analysis in the pharmaceutical, biotechnology, and/or contract research organization industries. Preferred Skills: * Extensive knowledge of SAS/BASE, SAS/STAT, and Macros * Experience working with heterogeneous data structures * Ability to work independently and in team environment and adept at managing multiple competing tasks * Good understanding of clinical data, statistics and pharmaceutical development * Good understanding of various study designs and related dataset considerations (parallel, crossover, blinded) * Knowledge and experience using SDTM and ADaM data structures * Knowledge of FDA and ICH guidance * Knowledge of clinical trial conduct and reporting requirements for clinical trials * Knowledge of SAS programming techniques needed to produce outputs in accordance with specifications *Position#4* Role : Sr. Statistical Programmer Location : Boston MA Rate : Best Duration : Long Functional Area: Medicines Development & Medical Affairs - Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications - Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH - Create all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE - Work with all types of safety data and coding dictionaries (MedDRA and WHODRL) commonly used by the pharmaceutical industry - Work in a team environment providing technical leadership and solving clinical trial reporting problems of moderate to high complexity within budget and customary time line constraints while assuring high quality standards - Perform quality control checks of SAS code and output produced by other Statistical Programmers Position Qualifications/ Minimum Qualifications: - Bachelor's degree in Biostatistics, Statistics, Computer Science, or a related field - 5 years of SAS and relevant pharmaceutical industry experience, including CDISC SDTM and AdaM models *Position#5* Role : Clinical SAS Programmer Location : Berkeley Heights NJ Rate : Open Duration : Long Responsibilities will include, but are not limited to, the following: 1. Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. 2. Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. 3. Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. 4. Ensure consistency and adherence to standards within their therapeutic area. 5. Provide programming support for the preparation of integrated reports, submissions and post-submission activities. 6. Serve as the lead programmer in support of NDAs, sNDAs. 7. Oversee the services provided by CROs. 8. Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros. 9. Provide training on departmental SOPs/WPs and standard programs. 10. Contribute to the creation of naming conventions and standards for the programming environment. 11. Participate in industry wide technical discussions. *Skills/Knowledge Required: * * Bachelor's degree in life science, statistics, mathematics, computer science, or related field is required; Master's degree is preferred. * 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor's degree; or 8 plus years experience with a MS/MA degree. * Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs. * Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats. * Demonstrated skills in using additional software tools and applications (e.g. MS office, XML). * Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. * Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. * In-depth understanding of regulatory, industry, and technology standards and requirements. * Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. * Demonstrated ability to work in a team environment with clinical team members. * Excellent planning and project management skills. * Good interpersonal, communication, writing and organizational skills. * Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM, ADaM, eDC. *Your co-operation will assist us to serve you better!* *Ghouse Shaik* *Trustek Inc* 732-393-1313 Extn 109 | Fax : 866-294-1314 | [email protected] 1001 Durham Ave,Suite 306 | South Plainfield, NJ 07080 | gtalk : Ghouse.Limrah www.trustek.com -- You received this message because you are subscribed to the Google Groups "J2EE_J2EE" group. 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