Director/Sr. Director, Statistical Programming
Artiva Biotherapeutics Inc., San Diego, California, United States, 92189
Overview
About Artiva: Artiva is a clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients with autoimmune diseases and cancers. AlloNK is an allogeneic, off-the-shelf NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. Artiva is evaluating AlloNK in three ongoing clinical trials for B-cell driven autoimmune diseases, including two company-sponsored trials (systemic lupus erythematosus with or without lupus nephritis, and a basket trial across autoimmune diseases) and an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting solid and hematologic cancers. Artiva was founded in 2019 and is headquartered in San Diego, California. For more information, visit www.artivabio.com.
Job Summary Director/Sr. Director, Statistical Programming: Lead the Statistical Programming function for Artiva’s clinical development programs. Contribute to the vision, direction, and strategy of the function and collaborate with clinical development and study teams to identify and meet their needs for statistical programming support.
Duties / Responsibilities
Lead and oversee statistical programming activities across clinical programs.
Establish and maintain program standards, processes, and best practices aligned with regulatory expectations.
Use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format.
Ensure programming deliverables meet timelines, quality standards, and submission requirements.
Contribute to the preparation of regulatory submissions.
Must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge of statistical programming processes, procedures, and roles.
Support responses to regulatory questions and inspections related to programming and data standards.
Ensure filing of study documentation is maintained to standard according to processes and is acceptable for audit.
Manage adherence to all company policies, SOPs, and other controlled documents; ensure programming activities adhere to departmental standards.
Evaluate, develop, revise, implement, and ensure compliance with functional guidelines, policies, and SOPs.
Collaborate across functional areas to ensure programming needs are met with regard to study data specifications, applications, and computing environment support.
Collaborate with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions to address programming needs.
Collaborate with Preferred Vendor management regarding governance, recruiting needs, contract development, signatures, and other partnership requirements.
Requirements
PhD/PharmD with 8+ years of experience, or Master’s with 10+ years, or Bachelor’s with 12+ years of experience.
10+ years of statistical programming experience in the biotech/pharmaceutical industry.
Extensive experience leading both early- and late-phase clinical studies, including programming and validation of SDTM and ADaM datasets, tables, figures, and listings.
Expert-level SAS programmer with experience delivering complex programming assignments, macros, and analyses.
Experience in management of CROs with respect to statistical programming.
Ability to build and maintain strong collaboration with key stakeholders across the organization.
Benefits
A beautiful facility
An entrepreneurial, highly collaborative, and innovative environment
Comprehensive benefits, including Medical, Dental, Vision; Group Life Insurance; Long Term Disability (LTD); 401(k); Employee Assistance Program (EAP); Flexible Spending Account (FSA); Paid Time Off (PTO); company holidays including year-end week; and a recognition program with Bonus.ly points system.
Base Salary: $210,000 – $270,000. Exact compensation may vary based on skills and experience.
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Job Summary Director/Sr. Director, Statistical Programming: Lead the Statistical Programming function for Artiva’s clinical development programs. Contribute to the vision, direction, and strategy of the function and collaborate with clinical development and study teams to identify and meet their needs for statistical programming support.
Duties / Responsibilities
Lead and oversee statistical programming activities across clinical programs.
Establish and maintain program standards, processes, and best practices aligned with regulatory expectations.
Use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format.
Ensure programming deliverables meet timelines, quality standards, and submission requirements.
Contribute to the preparation of regulatory submissions.
Must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge of statistical programming processes, procedures, and roles.
Support responses to regulatory questions and inspections related to programming and data standards.
Ensure filing of study documentation is maintained to standard according to processes and is acceptable for audit.
Manage adherence to all company policies, SOPs, and other controlled documents; ensure programming activities adhere to departmental standards.
Evaluate, develop, revise, implement, and ensure compliance with functional guidelines, policies, and SOPs.
Collaborate across functional areas to ensure programming needs are met with regard to study data specifications, applications, and computing environment support.
Collaborate with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions to address programming needs.
Collaborate with Preferred Vendor management regarding governance, recruiting needs, contract development, signatures, and other partnership requirements.
Requirements
PhD/PharmD with 8+ years of experience, or Master’s with 10+ years, or Bachelor’s with 12+ years of experience.
10+ years of statistical programming experience in the biotech/pharmaceutical industry.
Extensive experience leading both early- and late-phase clinical studies, including programming and validation of SDTM and ADaM datasets, tables, figures, and listings.
Expert-level SAS programmer with experience delivering complex programming assignments, macros, and analyses.
Experience in management of CROs with respect to statistical programming.
Ability to build and maintain strong collaboration with key stakeholders across the organization.
Benefits
A beautiful facility
An entrepreneurial, highly collaborative, and innovative environment
Comprehensive benefits, including Medical, Dental, Vision; Group Life Insurance; Long Term Disability (LTD); 401(k); Employee Assistance Program (EAP); Flexible Spending Account (FSA); Paid Time Off (PTO); company holidays including year-end week; and a recognition program with Bonus.ly points system.
Base Salary: $210,000 – $270,000. Exact compensation may vary based on skills and experience.
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