*Hi Professionals,*
*Kindly let me know if you have candidates for below position, and you can send good profiles to [email protected] <[email protected]>* *Thanks! --- Nicole Xie* *Manager/Sr. Mgr, Statistical Programming* South San Francisco *Job Purpose* The Statistical Programming group provides services to summarize data from clinical trials for the purpose of regulatory submission, publication, and data exploration. Senior Manager of Statistical Programming provides statistical programming expertise and hands on support to clinical projects across multiple therapeutics areas. Provide strong technical programming support. Contribute to activities in statistical systems development, validation and implementation of SAS macro utility /programs and associated tools. Contribute in building an efficient statistical programming Infrastructure. *Duties and Responsibilities* The duties and responsibilities include but are not limited to the following: - Oversees effort to determine and implement regulatory submission guidelines and company standards related to submission datasets and table/listings/figures. - Ensure proper implementation of statistical analysis plans and develop analysis data set specifications - Participate in the lead task forces and new initiatives, while maintaining current knowledge of programming practices and development within the industry. - Create tools to improve programming efficiency. - Ensure the quality work through ongoing quality management and review to ensure high quality and timely deliverables - Provides in-depth critical review of global standards related to CRF designs and database designs - Collaborate with Data Management to implement the CDISC standard at the CRF and database build-up stage. *Qualifications* - M.S. in Statistics, Epidemiology, Computer Science or other closely related field to programming with minimum 15 years of experience in statistical programming with at least 10 years of relevant pharmaceutical/biotech industry experience. - Highly competent in SAS programming and macro development. Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routine situation - Direct experience leading teams supporting NDA and EMEA filings. Experience using industry standards such as CDASH, SDTM, and ADaM. Thorough understanding of ICH Guidelines and relevant regulatory requirement. - Excellent organizational skills and the ability to delegate and prioritize work. - Self-motivated and the able to work independently, excellent time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work. - Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions on a regular basis and communicate these clearly. -- You received this message because you are subscribed to the Google Groups "as400placements1" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send an email to [email protected]. Visit this group at https://groups.google.com/group/hrccpl. For more options, visit https://groups.google.com/d/optout.
