**Position Summary:** **The Senior Manager, Statistical Programming is responsible for the organization of a statistical programming group that supports multiple drug development programs. The incumbent will manage a group of programmers who develop statistical programs that generate analysis datasets, produce outputs for tables and graphs, validate statistical programs,** **write** **general SAS application codes, prepare documentation for electronic submissions, and explore new methodologies to improve productivity of statistical programming.** **Essential Duties & Responsibilities:** **Collaborate with Programming Product lead and project** **leads** **in the resource planning, allocation and assignment of programmers.** **Address resourcing to adequately staff projects as needed.** **Lead or contribute to departmental process and standards initiatives such as** **macro tools, innovation,** **CDISC standards implementation.** **Contribute to the development and implementation of programming resource algorithm.** **Oversee the work of internal and contract programmers, provide guidance, and mentoring to programmers in statistical programming methodologies.** **R** **esponsible for career development of** **all** **programmers in the team.** **Contribute** **to** **the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming.** **Oversee the work of staff in support of clinical trials, ad-hoc analysis requests, data validation, etc. in accordance with all relevant statistical regulatory guidance and standards.** **Be a technical resource for programming group to provide advice on complex programming tasks and/or standards.** **Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance** **_(For all Supervising Managers)_** **Participate and support the development of TAUG (therapeutic area users guide) following CDISC Industry standards** **Represent statistical programming in cross-functional teams and process improvement initiatives.** **Contribute to department culture building and engagement** **Other duties as assigned** **Core Competencies, Knowledge and Skill Requirements:** **PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)** **Knowledge of SDTM and ADaM standards, able to write CDISC standard dataset specifications and follow specifications to create SDTM and ADaM datasets (as needed)** **Computer programming using SAS** **Fundamentals of project planning and management** **Drug development process** **Communication & Interpersonal Skills:** **Excellent verbal and written communication skills** **Ability to effectively collaborate in a dynamic environment** **DESIRED BACKGROUND AND EXPERIENCE:** **Experience leading teams supporting FDA/EMEA/CDE filings** **.** **Solid knowledge and hands-on experience of CDISC standards such as CDASH, SDTM, and ADaM** **Experience leading or working with centralized teams for Statistical Programming** **Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks.** **Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction.** **Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership).** **Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should** **priorities** **change (judgment and decision making).** **Experience in development and implementation of statistical programming standards and procedures** **Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research. Experience with oncology trials.** **Expert level SAS programmer with experience in delivering complex programming assignments and analysis. Proficient in developing** **their** **own code as well as modifying existing code.** **Education:** **Master's degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience** **Experience:** **Minimum 7+ years' clinical research and development programming experience using SAS** **2+ years of demonstrated leadership experience** **TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT** **(AS APPROPRIATE FOR THE POSITION)** **Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)** **Ability to work on a computer for extended periods of time.** **Regularly required to sit for long periods of time, and occasionally stand and walk.** **Regularly required to use hands to operate computer and other office equipment.** **Close vision required for computer usage.** **Occasionally required to stoop, kneel, climb and lift up to 20 pounds.** All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.