Associate Director, Clinical Programming

Associate Director, Clinical Programming

Direct Hire Full-Time Role

Salary Range: $200,000 - $220,000 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

The Associate Director, Clinical Programming (CP) is responsible for developing program specifications, programming listings, and reports, and providing other clinical programming support for assigned studies. This person is a department-level contributor and may have oversight of junior CP staff. This role must effectively interface with Data Management, Statistics, Statistical Programming, Clinical Operations, Clinical Science, and other appropriate functional area teams.

Duties and Responsibilities:

• Provides oversight to internal CP and/or consultant CP staff.
• Directs the activities of direct reports and/or consultant CP staff to ensure quality and compliance.
• Manages clinical programming and EDC system timelines to coordinate and synchronize deliverables with the overall study timelines.
• Adhere to CDISC (Clinical Data Interchange Standard Consortium), utilizing CDASH guidelines and best practices to facilitate creation of SDTM (Study Data Tabulation Model) and ADAM (Analysis Data Model) standards.
• Create Metric/Status Reports [i.e., Coding Metrics, Drug Dispensation Metrics, Subject Status Reports, BOXI Reports for Medidata Rave Studies] based on study-specific specs and requirements.
• Create Clinical Data Review Tools [i.e., Data Listing Reports (DLRs); External Data Reconciliation Listings, Medical Safety Listings for reconciliation for all studies based on study-specific specs and requirements.
• Create Lab, Pharmacokinetics (PK), and Pharmacodynamics (PD) reconciliation reports.
• Participate in study meetings with Clinical Science, Clinical Operations, Data Management, Safety, and Statistical teams to create specifications and develop reports.
• Program / generate ad-hoc reports and listings for Study Management Team (i.e., medical monitors etc.), regulatory submissions and inspections.
• Responsible for the development of data transfer specifications, processing of clinical data downloads, and data transfers to/from service providers and within the company.
• Validate SAS programs for Clinical data review listings, Metrics, and reconciliation reports following the departmental validation procedures.
• Create a DOS/UNIX batch script to schedule SAS jobs and distribute the reports to the corresponding clinical team.
• Work with various technologies such as SAS, SQL Server, Spotfire, BOXI, and Crystal Reports.
• Responsible for medical coding data transfers (MedDRA and WHO Drug) to/from the Centralized Coding vendor for processing and creating coding reports to support the company's Coding process.
• Importing and extracting data by connecting the SAS System to database systems such as Microsoft SQL, Excel, and exporting data to generate dynamic reports in HTML, RTF, XML, Excel, and PDF formats by using SAS/ODS.
• Program in Medidata Rave EDC databases for the company studies based on approved mock CRFs and specs provided, and works with the technical infrastructure of data management, and works with IT to ensure local IT infrastructure meets clinical data management needs and global standards.
• Contributes to the development and implementation strategy for the improvement of productivity and standardization of study build, database setup, and programming activities.

Requirements and Qualifications:

• Bachelor's degree in Life Sciences, Computer Sciences, or Mathematics with a minimum of 7+ years of SAS programming and/or Data management experience in the pharmaceutical or biotechnology industry, depth, and exposure to DM and/or programming-related tasks considered in lieu of the minimum requirement.
• Requires solid knowledge of clinical data management principles, clinical trials process, and regulatory requirements.
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment .
• Able to communicate and collaborate effectively with cross-functional teams (Clinical Operations, Clinical Scientists, and Statisticians) in face-to-face conversations, by telephone, and by email.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Strong, well-rounded technical skills (SAS, EDC systems, MS Word, Excel, PowerPoint) and knowledge of industry standards (CDISC, SDTM, CDASH).
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA.
• Proven ability to work both independently and in a team setting.

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