*Note: Please forward resumes to mah...@trustek.com <mah...@trustek.com>*
Job Title: Clinical / Statistical SAS Programmer Location: Woodcliff Lake NJ/ Woodcliff Lake NJ / Hopewell NJ/ Boston MA / Berkeley Heights NJ Duration: 6 Months *MUST BE LOCAL FACE TO FACE INTERVIEW REQUIRED.* 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 *Thanks & Regards: * *Mahesh, * *Sr. Technical Recruiter * *Trustek Inc * *Office: 732-393-1313 ext-112| * *Fax: 001(866) -294-1314 |* *E: mah...@trustek.com <mah...@trustek.com> | www.trustek.com <http://www.trustek.com> |* *1001 Durham Ave,Suite 306 | South Plainfield, NJ 07080 |* *Yahoo IM: mahesh.saxon* -- You received this message because you are subscribed to the Google Groups "OracleD2K" group. To unsubscribe from this group and stop receiving emails from it, send an email to oracled2k+unsubscr...@googlegroups.com. To post to this group, send email to oracled2k@googlegroups.com. Visit this group at http://groups.google.com/group/oracled2k. For more options, visit https://groups.google.com/d/optout.
