Full-Time Associate Director, Statistical Programming
Apogeetherapeutics is hiring a remote Full-Time Associate Director, Statistical Programming. The career level for this job opening is Manager and is accepting USA based applicants remotely. Read complete job description before applying.
Apogeetherapeutics
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About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. is a well-funded, Nasdaq listed company offering a fast-paced, dynamic environment. At Apogee, you'll shape the culture, take on various roles, and grow professionally.
Role Summary Seeking an Associate Director of Statistical Programming to lead statistical programming activities supporting clinical trial projects. This role builds programming processes for clinical studies and submissions, manages programmers and CROs, and provides support to cross-functional teams.
Key Responsibilities
- Lead statistical programming for one or more clinical studies.
- Provide oversight to programming vendors.
- Review and validate datasets and TFLs programmed by vendors.
- Collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and others to deliver high-quality data deliverables.
- Develop and implement data review/reporting tools and statistical applications.
- Participate in developing and implementing statistical programming processes and standards.
- Review study documents (SAP, DMP, CRF, etc.) and provide expert feedback.
- Build and mentor a team of programmers.
- Generate ad hoc analyses.
Ideal Candidate
- Master's Degree in Statistics, Biostatistics, or related field
- 10+ years' experience in clinical trial programming (biotech/pharma)
- Strong SAS programming skills, experience with R
- CDISC (SDTM, ADaM) expertise
- Excellent organizational, communication, and interpersonal skills
- CRO management experience
- Growth mindset, commitment to a psychologically safe environment
- Knowledge of ICH guidelines and FDA/EMA/other regulatory guidance
- Experience working in a remote virtual environment
- Ability to travel up to 10% (min 4 times/year)
- Must exhibit Apogee's CORE values (Caring, Original, Resilient, Egoless)
Salary Range $185,000 - $205,000 (negotiable).