The position serves the critical role for providing direction and oversight to programming team/activities. Managing liaisons across the company, with external alliances, vendors, and with regulatory agencies. The position will also be responsible for providing input into submission strategies and will support process and infrastructural improvement, resource and cost management for multiple oncology clinical studies/programs.
Manages collaborations with external alliances for all programming related activities. Ensure successful and effective coordination and communications
Manages, reviews and / or executes statistical programming deliverables for planned statistical analysis, related to study monitoring, clinical study reports, data integrations and regulatory query responses, covering multiple compounds and studies Leads global submission activities including cross company projects. Acts as a programming functional and technical
expert to support submission strategy planning, regulatory communication
Sets and leads key business objectives or projects within the department; Leads development and updating company policies/SOPs; Recommends enhancements for improvement Manages and leads development and enhancement towards standardization and process for consistency, efficiency and accuracy Supports computer infrastructure improvement with data integrity by working with internal resources and external vendors Participates in recruitment activities; Supports planning and directing work between internal resources and external vendors Manages CROs and contractors with regarding the compliance, deliverable qualities, timelines and budgets
Minimum of a Master degree in Biostatistics (preferred), Statistics, computer science, or related discipline. Bachelor’s degree with extensive experience might also be considered.
At least 12 years relevant experience in statistical programming in the pharmaceutical industry/CRO environment with people and project management experience.
Highly experienced in clinical development statistical programming methods and processes in industry setting required.
Regulatory submission experiences in the area of Oncology indications. Have lead programming activities involving CDISC SDTM, ADaM, eSub.
Experience with CRO oversight.
Strong organizational skills with ability to effectively manage multiple studies/projects.
Excellent technical writing and verbal communication skills.
Source: Job Diva – Job Listing