Senior Manager, Statistical Programming/SAS Programming - San FranciscoTanner and Associates is recruiting a Senior Manager, Statistical Programming/SAS Programming for a large biotech company based in San Francisco. Full relocation services provided within the US.Summary:
- The Senior Manager, Statistical Programming will be responsible for providing project management of statistical programming activities.
- They will deliver against the overall protocol timeline, cost, and quality goals through matrix communication with the study team and will be accountable for the provision of standard and non-standard datasets, tables, listings, and figures that are required for the study reports, submissions, or publications.
- The Senior Manager, Statistical Programming will enforce standard programming approaches, provide continuous improvement of processes, and communicate effectively not only within the teams and functional lines but also with external resources.
- In addition, they will lead the programming team to prepare for electronic submission activities including project plans, specifications, resource allocation, and deliverables in a timely fashion.
- They will provide filing, approval, and regulatory programming support for all aspects of a submission and contribute technical expertise to team deliverables while coaching/training new programmers on processes related to team deliverables.
- They will also assess the impact of procedural or system changes and develop/implement strategies to maintain consistency of programming.Qualifications:
- MS degree and a minimum of 8 or more years of experience in Statistics, Computer Science, or a related field within a clinical programming organization, preferably within medium-large pharmaceuticals or CRO. 3 or more years of experience in managing statistical programming aspects of clinical trials and direct reports, with NDA/BLA experience a plus.
- Significant knowledge and experience with SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP, and applicable regulations, as well as proven knowledge of regulatory document and reporting systems.
- Experience must include in-depth knowledge of CDISC in SDTM and ADaM, Metadata, and controlled terminologies.
- Proficiency in SAS and at least one programming environment such as VB Scripts and JAVA.Please send a CV and contact information to Jake Tanner at ...@biotechsearch.com. US candidates only please. #J-18808-Ljbffr