Associate Director, Statistical Programming

Associate Director, Statistical Programming

Avenzo Therapeutics, Inc. ("Avenzo" or "Company") is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc., respectively). Our team is passionate about and committed to advancing a pipeline of potential best-in-class targeted oncology programs that make a difference in the lives of people with cancer.

The Company is headquartered in San Diego, California.

Reporting to the Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for hands-on SAS programming that requires providing oversight to CRO statistical programmers and programming support and guidance for internal deliverables and regulatory submissions while ensuring conformance to CDISC standards and submission guidelines. Based on company needs, this position will be required to lead one or more early Phase or late phase studies/programs.

Essential Job Functions and Responsibilities:

• Provide statistical programming leadership, including timelines, vendor oversight, and delivery of compliant outputs (e.g., FDA 21 CFR Part 11, GxP)
• Lead and execute programming deliverables, including CDISC datasets (SDTM, ADaM), TLFs regulatory submissions, SAPs, and supporting documents
• Oversee the programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer's Guide, and TLFs
• Hands-on programming and management of in-house deliverables
• Experience in statistical programming for early and late phase oncology trial studies
• Proven ability to lead programming for clinical study protocols.
• Proficiency in SAS Programming for analysis datasets, tables, listings, and figures.
• Experience in small to mid-sized biotech/pharma settings and contributing to processes, SOPs and standards
• Proactive, innovative mindset with the ability to thrive in a fast paced, team setting, collaborating environment providing programming timelines for various deliverables

Preferred Qualifications:

• Bachelor's degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, PhD) with 8+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• 6+ years of Statistical Programming experience with early or late phase oncology trial studies
• In-depth knowledge of CDISC standards
• Technical expertise and knowledge of statistical analyses using SAS
• Excellent written and verbal communication skills
• Good working knowledge of ICH, FDA and GCP regulations and guidelines
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset
• This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel

Physical Demands and Work Environment:

Physical Demands:

• Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
• Constant or frequent sitting, standing, or walking
• May lift and/or move objects of various weights

Work Environment:

• Remote:
  Home office; expected to travel to and work from the Company's headquarters in San Diego from time to time
• San Diego-based:
  On-site requirement (Monday through Thursday)
• Noise level in the work environment is usually moderate
• Fast-paced, time sensitive environment with frequently changing priorities
• Handle multiple projects simultaneously

Reasonable accommodation may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

Salary Range:

The salary range for this position is $184,000 to $197,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the…