Edgewise Therapeutics · 4 days ago

Director, Head of Statistical Programming

Massachusetts, United States

Contract

Remote

Senior Level, Lead/Staff, Director/Executive

$195K/yr - $235K/yr

10+ years exp

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Responsibilities

Work closely with the Edgewise Therapeutics cross-functional team, including, but not limited to Statistics, Medical, Clinical Operations, and Data Management;

Comply with applicable national and international laws, regulations, including, but not limited to applicable Good Clinical Practices (GCPs), and Data Privacy Regulations;

Comply with Edgewise Therapeutics policies, standard operating procedures, and other written instructions;

Demonstrate effective leadership and working skill in teamwork, delegation, organization and coordination;

Demonstrate a high level of professionalism and personal integrity when representing the Company;

Assisting with the selection of Contract Research Organizations (CROs) or other vendors for statistical, programming activities, covering both programming for data standards compliance, as well as tables, listings and figures (TLFs);

Oversight of all statistical programming activities done by co-development partners, CROs or other vendor(s). This oversight will include but not be limited to:

Review and validation of technical programming specifications and programs

Review of SDTM and ADaM datasets

Quality check of SAP specific tables, listings, and figures

Filing of all statistical programming related study documentation;

Ensures programs and processes are developed, implemented, and effectively administered;

Oversees the investigation and implementation of new procedures and technologies relating to statistical programming;

Lead SOP development for standardization of statistical programming processes. Ensure that appropriate SOPs and guidelines are available, understood and followed;

Input and accountability for development of timelines, project management of all end-to-end statistical programming deliverables in collaboration with cross-functional team members and vendors on assigned studies;

Ensures that out-sourced statistical programming tasks are performed according to GCP, approved SOPs, and protocol;

Manages performance and quality issues with vendors and escalates when needed;

Participates as subject matter expert during regulatory inspections and/or vendor audits as needed;

Provides input into the budget for any statistical programming software, systems, and/or activities;

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Statistical ProgrammingClinical Trial KnowledgeSAS ProgrammingCDISC-SDTM/ADaMProject ManagementXMLMedDRAWHODRL