Manager/Sr. Manager, Statistical Programming

Company: Dicerna
Location: Cambridge
Posted on: September 14, 2020

Job Description:

Manager/Sr. Manager, Statistical Programming. Dicerna. -. Cambridge, MA 02140. Full Job Description. We are looking to hire a Manager, Statistical Programming. This individual will be responsible for the oversight of statistical programming activities for all clinical development programs. This individual will proactively oversee the quality and timely delivery of all statistical programming deliverables. This position will report to the Director of Biostatistics.. Key Responsibilities. Provide oversight of statistical programming activities of CRO across multiple studies.. Collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, and other functions to provide programming support.. Oversee the activities of CRO programming team to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality.. Perform programming QC/validation of SAS code for SDTM datasets, ADaM datasets and TFLs.. Review CDISC specifications for SDTM and ADaM datasets as well as define.xml, reviewers guide documents and Pinnacle 21 validation reports.. Program TFLs for study related ad hoc analyses, posters, and presentations.. Participate in internal study team meetings as well as teleconferences with vendors and study personnel.. Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans (SAP), Mock Tables, Figures and Listings (TFL) shells.. Review and ensure adherence to programming budgets.. Participate in the creation of company data and programming standards.. Participate in the development and review of Statistical Programming SOPs.. Mentor junior statistical programmers.. Qualifications. Master’s degree in Biostatistics, Computer Science or a related field plus five to seven years of statistical programming experience in the pharmaceutical / CRO industry; or Bachelor’s degree in in Biostatistics, Computer Science or a related field with at least 8 to 10 years of relevant industry experience. Strong knowledge with CDISC standards for SDTM and ADaM and statistical programming requirements for regulatory submissions. Excellent SAS programming skills, including SAS/Base, SAS/STAT, SAS/GRAPH, SAS/SQL and SAS/Macro. Experience with NDA/BLA or other regulatory filing, including ISS or ISE. Global clinical trial and CRO management experience. Strong working knowledge of FDA/EMA & ICH/GCP regulations and guidelines. Excellent written and verbal communication skills. Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, team-based environment. Thousands of employers search for candidates on Indeed

Keywords: Dicerna, Cambridge , Manager/Sr. Manager, Statistical Programming, Other , Cambridge, Massachusetts