Senior Manager, Statistical Programming/SAS Programming – San Francisco
Tanner 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 and provide continuous improvement of processes, communicating effectively within the teams and functional lines as well as with external resources.
- In addition, they will lead the programming team to prepare for electronic submission activities including project plans, specifications, resource allocation, and timely deliverables.
- 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 or 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, with 3 or more years of experience in managing statistical programming aspects of clinical trials and direct reports; NDA/BLA experience is 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 ...@www.biotechsearch.com. US candidates only please.
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