AstraZeneca
Director, Statistical Programming
Wilmington, Delaware, United States of America · Director
Sponsorship not specified$165k-$248kDetected 2 days ago
StatisticsProject ManagementVendor ManagementPerformance ManagementClinical TrialsPharmacovigilanceSASLeadershipCommunicationCollaborationProblem SolvingTime ManagementMentoringBiostatisticsEpidemiology
About the role
- 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 may be responsible for the direct-line management of the statistical programmers through Associate Director level staff.
Responsibilities
- 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.
- You will be responsible for: Serve as the Lead Programmer and Manager of the statistical programming efforts for a compound / indication.
- Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
- Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
- Develop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs.
- Independently develop and validate programs that generate protocol specific efficacy tables, listings, figures/graphs using Alexion specifications.
- Directly support the Statistical Programming Sr.
- Create and/or review programming plans and ensure appropriate resource allocation and prioritization.
- Manage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards.
Requirements
- He/she must be able to identify project resource requirement needs and manage large external provider contract budgets.
- 10 + years statistical programming experience in the CRO or Pharmaceutical Industry.
- 7+ years people and / or project management experience in the CRO or Pharmaceutical Industry.
- Strong ability to solve problems, recommend process improvements, and execute on process improvements.
- Any other activities as required.
- As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer
Nice to have
- Ensuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
- Provide secondary reviews of Statistical Programming deliverables.
- Director in all aspects of the management and development of the Statistical Programming team.
- Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.
- Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
- and ensure all programming activities adhere to departmental standards.
- Participate in strategic development meetings across departments.
Compensation
- Forecast quarter, annual, and 3-5 year budget.
Benefits
- 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.
Equal opportunity
- If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.