Principal Statistical Programmer, Oncology BDM
Location: Cambridge Massachusetts
Description: Novartis is currently seeking to employ Principal Statistical Programmer, Oncology BDM right now, this occupation will be placed in Massachusetts. For complete informations about this occupation opportunity please give attention to these descriptions. mso-fareast-font-family: Calibri;mso-fareast-theme-font: minor-latin;mso-ansi-language:
EN-US;mso-fare! ast-language: ZH-CN;mso-bidi-language: AR-SA" >Responsible for all programming aspects (including analysis datasets, pooled datasets, listings, figures, tables) of individual Phase I-IV clinical trials and project-level activities for clinical drug development program for Oncology franchise. Apply scientific and technical skills in statistical programming (SAS, GRAPH, SQL, STAT and Macro, CDISC SDTM and ADAM) to develop and review Report Analysis Plan (RAP), Validation Analysis Plan (VAP) modules, protocol and annotated CRFs to program macros and TLGs with statistical analysis for CSR, ISS, ISE and related tasks. Liaise with Biometrician and statistical scientific counterparts within team of statisticians and clinicians as scientific lead for programming expertise. Develop analysis datasets for tumor assessment using RECIST criteria. Lead full execution of final production output generation of quality, timely programming deliverables for CSRs, regulatory submissions/! interactions, publications, and market promotions within globa! l drug development program. In collaboration with Biometrician/Statistical Scientist, develop project-level programming standards and ensure compliance with project-level/disease-area/company standards. Support development of disease-area programming standards as required, following internal guidelines. Ensure integrity of programming/computing solutions. Write programming requirement specifications. Ensure documents and specifications are consistent, comply with company standards by providing input into study protocols, eCRFs and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities. Lead team of programmers/program (according to established specifications) analysis datasets, pooled datasets, listings, tables, figures, and listings for Phase I-IV clinical trials and for regulatory submissions (SCS, SCE and RMP/safety update) and for other project support (publications and market promotion) with high quality and according to ! established milestones. Prepare Case Report Tabulations for submission as required. Support quality control and quality audit of deliverables. Provide technical expertise to consult, train and mentor other programmers. Maintain records for assigned projects and archive trial/project analysis, associated documentation. Participate in selection of CROs/external vendors, and supervise CRO statistical reporting activities. Review and validate deliverables from external vendors. Provide input on process improvement initiatives, and participate in non-clinical project activities. Minimum requirements Principal Statistical Programmer, Oncology BDM sought by Novartis Institutes for Biomedical Research, Inc. for Cambridge, MA location. Must possess Masters or foreign equivalent degree in Biomedical Engineering, Mathematics, Statistics or directly related field, and 3 yrs of industry experience in statistical analysis and programming supporting Oncology or other disease franchise, at! least 2 yrs of which include developing analysis datasets for tumor as! sessment using RECIST criteria with demonstrated expertise in SAS (GRAPH, SQL, STAT and Macro), CDISC SDTM and ADAM. Experience must include CSR, ISS, ISE for submission, leading team of programmers, review/validation of external vendor deliverables, writing programming requirement specifications and collaboration with programmers, clinicians and statisticians. Respond to: NIBRI, Attn: HR/Staffing/Perm. Req. 116090BR, 200 Technology Square, 10th Fl., Cambridge MA 02139, or apply online: www.novartis.com/careers. Novartis is an EOE.
- .
If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Novartis.
If you interested on this occupation just click on the Apply button, you will be redirected to the official website
This occupation starts available on: Mon, 25 Mar 2013 14:15:54 GMT
0 comments:
Post a Comment