Associate Director, Statistical Programming

Role Description

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.

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

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

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

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 industry, education, and skills and certifications.

Benefits

Eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance

Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness

Employees will also be able to enroll in the Company’s 401(k) plan

Accrue 10 hours of paid vacation time every month

Accrue 1 hour of paid sick leave for every 30 hours worked

Enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies

Other Compensation

The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies.

Equal Employment Opportunity

Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individual’s actual or perceived protected characteristic or characteristics, or any combination of protected characteristics.

Notice to Search Firms/Third Party Agencies

Avenzo does not accept unsolicited resumes from recruiters, employment agencies or search firms without a valid, executed search agreement in place.