Associate Director, Clinical Programming

Role Summary

We are seeking an Associate Director, Clinical Programming, to join the Data Management team. In this position you will be responsible for both managing and analyzing clinical trial data using programming languages like SAS, R, and Python to ensure data integrity, generate tables and figures, and support regulatory submissions. Key responsibilities include data cleaning, developing statistical programs, creating reports, validating outputs, and collaborating with statisticians and data managers to assess drug safety and efficacy. Ensure compliance with CDISC standards and regulatory guidelines to support decision-making.

Responsibilities

• Clean, validate, and transform raw clinical trial data from various sources into standardized formats, such as CDISC SDTM
• Participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports
• Develop and execute SAS programs (or other languages like R/Python) to create datasets, tables, listings, and figures (TLFs) as specified in the Statistical Analysis Plan (SAP)
• Responsible for building effective DM vendor relationships. This includes being involved in RFP development, contract negotiation and selection of DM CROs and/or technology, as needed
• Work closely with CROs to prepare and ensure proper development and execution of data management activities
• Review protocols to ensure database feasibility
• Perform statistical analyses support for the efficacy and safety evaluation of treatments
• Perform quality control (QC) checks on vendor programming work, including SAS code and generated outputs, to ensure accuracy and adherence to standards
• Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed
• Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashion, and to design analyses, interpret results, and solve programming challenges
• Ensure all programming and data activities comply with Good Clinical Practice (GCP) and regulatory agency guidelines
• Maintain comprehensive documentation of programming work for audit trails and regulatory submissions
• Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs
• Build and mentor a team of programmers to effectively support clinical trials and pipeline

Qualifications

• Bachelor’s Degree in a position relevant field, such as statistics, computer science, or scientific discipline preferred
• Minimum of 8 to 10 years of clinical programming in pharma/biotech industry
• Direct people management experience in a remote setting is a plus
• Late-stage regulatory submission experience (NDA, sNDA and BLAs) highly preferred
• Proficiency in statistical programming languages such as SAS
• Technology proficiency includes Data Management Systems
• Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality
• Familiarity with clinical data standards like CDISC SDTM and CDISC
• Extensive experience managing CROs and other data vendors
• Strong analytical and problem-solving skills to identify and resolve data issues
• Knowledge of Good Clinical Practice
• EDC and eCOA experience (Medidata, Veeva, etc.)
• Understanding of clinical trial design, protocols, and regulatory requirements
• Ability to keep pace in a fast-moving organization and navigate ambiguity
• Ability to communicate effectively with both technical and non-technical team members
• Meticulous attention to detail is crucial for data accuracy and consistency
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel 10-15% or as needed by the business