Stellenbeschreibungp br/The Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. Manages a team of programmers supporting clinical trial and integrated analyses, annual reporting, regulatory responses, publications, HTA requests and other purposes as needed within one or more therapeutic areas. /ppThe individual will work closely with the Senior Director, Clinical and Statistical Programming to advance the internal programming environment and statistical programming processes. Works closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards.br/Reporting Relationships: List other positions in the company that are reporting into this position or that this position reports into. /ppbr/bMain Responsibilities and Accountabilities: /b /pliWorking with the Biometrics Programming Leadership team, assess upcoming activities and resulting resource needs and allocate projects to people to ensure high quality, timely, delivery. Ensure realistic resource planning. /liliOversee the CRO delivery or manage the in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analysis. /lili Coordinating the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, response to regulatory requests, or other ad-hoc requests. /liliManages, hires, and mentors direct reports including annual evaluations and goal setting. /liliAs a member of the programming leadership team within biometrics, creates, maintains ensures compliance with programming process and strategy to facilitate accurate and timely analysis programming. /liliHelp bring state of the art programming methods and tools to the organization and drive automation of delivery, including AI. /liliCollaborate with Biometrics and other departments to ensure transition points in process are efficient and of high quality. /liliRepresents the company in outside professional organizations and meetings. /lipbr/bJob Qualifications and Experience Requirements: /b /ppbr/bEducation: /b /pp• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience /pp• Other degrees and certifications considered if commensurate with related programming experience. /ppbr/bExperience: /b /pp• At least 10 years of experience in the biotech, pharma, or CRO industries br/• Preferred 5 or more years of direct supervisory experience br/• Experience with CRO management and/or CRO work experience br/• Extensive understanding of clinical programming and/or statistical programming processes and standardsbr/• Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros, preferred managing team performing these activities as wellbr/• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)br/• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelinesbr/• Experience in working in cross-functional, multicultural and international clinical trial teamsbr/bCompetencies /b /pp• Coding in SAS, including SAS macro language br/• Interest and/or experience in expanding beyond SAS as the primary programming delivery tool br/• Experience in and passion for automatization of routine programming tasks br/• Broad knowledge of clinical development and processes br/• Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management br/• Ability to collaboratively work and provide leadership in matrix environment br/• A solutions oriented mindset br/• Fluency in technical requirements for CDISC compatible datasets and DDT files br/• Presentations of programming techniques at professional conferences is a plusbr/br/ /pppbbAbout CSL Behring /b /b /p /ppCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. /ppbr/CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. /ppTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at . /ppbOur Benefits /b /p
