Director of Technical Services
Net at Work
Associate Director, Clinical Programming
Apogee Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $185,000 - $210,000 per year
Job Level
Senior
Tech Stack
Google Cloud PlatformPython
About the role
- 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.
Requirements
- 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
Benefits
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- Flexible PTO
- Two, one-week company-wide shutdowns each year
- Commitment to growing you professionally and providing access to resources to further your development
- Apogee offers regular all team, in-person meetings to build relationships and problem solve
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SASRPythondata cleaningstatistical programmingreport creationdata validationclinical trial data analysisregulatory submissionCDISC standards
Soft skills
analytical skillsproblem-solving skillscommunication skillsattention to detailpeople managementcollaborationadaptabilitynavigating ambiguitytime managementleadership
Certifications
Bachelor’s DegreeGood Clinical Practice (GCP)ICH guidelines
