{"schemaVersion":"jobsearcher.job.v1","id":"c2fda92dc8b78d1ee0b49f41","url":"https://jobsearcher.com/jobs/c2fda92dc8b78d1ee0b49f41","canonicalUrl":"https://jobsearcher.com/jobs/c2fda92dc8b78d1ee0b49f41","title":"Director, Statistical Programming","description":"This is what you will do\nThe Director of Statistical Programming will be primarily responsible for overseeing statistical programming activities for multiple clinical studies within multiple Therapeutic Areas, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. He/she must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles. He/she will use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use his/her strong people management skills and supervisory skills to provide direct line management to statistical programmers and external partners, identify training needs and opportunities for optimizing staff utilization and employing the most efficient practices. He/she must be able to identify project resource requirement needs and manage large external provider contract budgets. He/she may be responsible for the direct-line management of the statistical programmers through Associate Director level staff.\n\nYou will be responsible for\n\nServe as the Lead Programmer and Manager of the statistical programming efforts for a compound / indication.\n\nDevelop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.\n\nIndependently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.\n\nDevelop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs.\n\nIndependently develop and validate programs that generate protocol specific efficacy tables, listings, figures/graphs using Alexion specifications.\n\nEnsuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.\n\nProvide secondary reviews of Statistical Programming deliverables.\n\nDirectly support the Statistical Programming Sr. Director in all aspects of the management and development of the Statistical Programming team.\n\nParticipate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.\n\nCreate and/or review programming plans and ensure appropriate resource allocation and prioritization.\n\nAct as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.\n\nManage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards.\n\nAssume direct line management responsibility of the statistical programmers, conducting performance reviews, setting and regularly reviewing objectives, providing guidance and mentoring, and developing and regularly reviewing training and career development plans.\n\nPlan and manage department budget. Forecast quarter, annual, and 3-5 year budget. Participate in strategic development meetings across departments.\n\nEvaluate, develop, revise, implement and ensure compliance to functional guidelines, policies, and SOPs.\n\nCollaborate across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications and computing environment support.\n\nCollaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.\n\nCollaborate closely with Preferred Vendor management in terms of governance, recruiting needs, contract development and signature, and any other partnership requirement that may arise.\n\nAny other activities as required.\n\nYou will need to have\n\n10+ years statistical programming experience in the CRO or Pharmaceutical Industry.\n\n7+ years people and / or project management experience in the CRO or Pharmaceutical Industry.\n\nAdvanced SAS programming skills in a clinical and statistical data environment across multiple therapeutic areas.\n\nThorough understanding of relational databases and their correlation to submission ready database structure.\n\nStrong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation.\n\nSignificant experience in a leadership capacity with a focus on identifying, leading and advancing talent.\n\nExperience working in a clinical development organization with a heavy emphasis on support of multiple, ongoing projects.\n\nThorough understanding of pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.\n\nThorough understanding of industry standards such as CDISC and 21CFR Part 11.\n\nStrong ability to solve problems, recommend process improvements, and execute on process improvements.\n\nAbility to lead and influence teams.\n\nExcellent verbal and written communication skills in a global environment.\n\nProven ability to work with cross functional teams, specifically Data Management, Biostatistics, Epidemiology, Clinical Operations, and Pharmacovigilance to initiate, lead and execute new initiatives and process improvements.\n\nRecognize behaviors that align with our values critical to the success of our employees, mission, and business objectives.\n\nPreferred\n\nBS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.\n\nCompetencies\n\nAccountability\n\nCollaboration\n\nDecision Quality\n\nDrive for Results\n\nPerseverance\n\nProblem Solving\n\nInforming\n\nPeer Relationships\n\nTime Management\n\nBuilding Effective Teams\n\nManaging Through Systems\n\nThe annual base pay (or hourly rate of compensation) for this position ranges from $165,095.20 - $247,642.80. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.\n\nOur mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.\n\n#J-18808-Ljbffr","company":"AstraZeneca","rawCompany":"astrazeneca","city":"Wilmington","state":"DE","isRemote":false,"isActive":false,"createdAt":"2026-07-24T03:20:29.290Z","occupations":[{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"},{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"},{"code":"11-9111.00","title":"Medical and Health Services Managers","slug":"medical-and-health-services-managers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Director, Statistical Programming","description":"This is what you will do\nThe Director of Statistical Programming will be primarily responsible for overseeing statistical programming activities for multiple clinical studies within multiple Therapeutic Areas, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. He/she must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles. He/she will use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use his/her strong people management skills and supervisory skills to provide direct line management to statistical programmers and external partners, identify training needs and opportunities for optimizing staff utilization and employing the most efficient practices. He/she must be able to identify project resource requirement needs and manage large external provider contract budgets. He/she may be responsible for the direct-line management of the statistical programmers through Associate Director level staff.\n\nYou will be responsible for\n\nServe as the Lead Programmer and Manager of the statistical programming efforts for a compound / indication.\n\nDevelop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.\n\nIndependently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.\n\nDevelop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs.\n\nIndependently develop and validate programs that generate protocol specific efficacy tables, listings, figures/graphs using Alexion specifications.\n\nEnsuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.\n\nProvide secondary reviews of Statistical Programming deliverables.\n\nDirectly support the Statistical Programming Sr. Director in all aspects of the management and development of the Statistical Programming team.\n\nParticipate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.\n\nCreate and/or review programming plans and ensure appropriate resource allocation and prioritization.\n\nAct as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.\n\nManage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards.\n\nAssume direct line management responsibility of the statistical programmers, conducting performance reviews, setting and regularly reviewing objectives, providing guidance and mentoring, and developing and regularly reviewing training and career development plans.\n\nPlan and manage department budget. Forecast quarter, annual, and 3-5 year budget. Participate in strategic development meetings across departments.\n\nEvaluate, develop, revise, implement and ensure compliance to functional guidelines, policies, and SOPs.\n\nCollaborate across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications and computing environment support.\n\nCollaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.\n\nCollaborate closely with Preferred Vendor management in terms of governance, recruiting needs, contract development and signature, and any other partnership requirement that may arise.\n\nAny other activities as required.\n\nYou will need to have\n\n10+ years statistical programming experience in the CRO or Pharmaceutical Industry.\n\n7+ years people and / or project management experience in the CRO or Pharmaceutical Industry.\n\nAdvanced SAS programming skills in a clinical and statistical data environment across multiple therapeutic areas.\n\nThorough understanding of relational databases and their correlation to submission ready database structure.\n\nStrong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation.\n\nSignificant experience in a leadership capacity with a focus on identifying, leading and advancing talent.\n\nExperience working in a clinical development organization with a heavy emphasis on support of multiple, ongoing projects.\n\nThorough understanding of pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.\n\nThorough understanding of industry standards such as CDISC and 21CFR Part 11.\n\nStrong ability to solve problems, recommend process improvements, and execute on process improvements.\n\nAbility to lead and influence teams.\n\nExcellent verbal and written communication skills in a global environment.\n\nProven ability to work with cross functional teams, specifically Data Management, Biostatistics, Epidemiology, Clinical Operations, and Pharmacovigilance to initiate, lead and execute new initiatives and process improvements.\n\nRecognize behaviors that align with our values critical to the success of our employees, mission, and business objectives.\n\nPreferred\n\nBS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.\n\nCompetencies\n\nAccountability\n\nCollaboration\n\nDecision Quality\n\nDrive for Results\n\nPerseverance\n\nProblem Solving\n\nInforming\n\nPeer Relationships\n\nTime Management\n\nBuilding Effective Teams\n\nManaging Through Systems\n\nThe annual base pay (or hourly rate of compensation) for this position ranges from $165,095.20 - $247,642.80. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.\n\nOur mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.\n\n#J-18808-Ljbffr","datePosted":"2026-07-24T03:20:29.290Z","dateModified":"2026-07-24T03:20:29.290Z","hiringOrganization":{"@type":"Organization","name":"AstraZeneca","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Wilmington","addressRegion":"DE","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"c2fda92dc8b78d1ee0b49f41"},"url":"https://jobsearcher.com/jobs/c2fda92dc8b78d1ee0b49f41"}}