Senior Director, Statistical Programming

Apogee Therapeutics

Senior Director in Statistical Programming overseeing clinical trials at Apogee Therapeutics. Leading statistical workflows and managing programming infrastructure in biopharmaceuticals.

Posted 4/30/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $270,000 - $295,000 per yearWebsite

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

Support the statistical programming function by implementing programming processes, standards, and SOPs for clinical trials
Contribute to the development and maintenance of SAS programming infrastructure, processes, and data standards
Lead programming activities for assigned projects and studies (e.g. leading submission), ensuring timely and high-quality deliverables
Manage and oversee CROs and external vendors to ensure quality and compliance with expectations
Collaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions
Develop and implement data review, reporting tools, and statistical applications in partnership with cross-functional teams
Review and validate SAS programs (SDTM, ADaM, and TFLs) generated internally or by CROs
Review SAPs, DMPs, CRFs, annotated CRFs, TFL specifications, and other study documents, providing expert programming input
Mentor and develop programmers, fostering a high-performing and collaborative team environment
Provide hands-on support for complex analyses and ad hoc requests as needed
Drive process improvements and efficiencies, including the adoption of automation and AI-based solutions in programming workflows

Requirements

What you’ll need

Master's Degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field
A minimum of 12–15 years of progressive clinical trial programming experience in the biotech/pharma industry, including leadership experience
Advanced SAS programming skills: experience with R or other statistical programming languages preferred
Strong experience and in-depth knowledge of CDISC standards (SDTM, ADaM) and controlled terminology
Experience supporting regulatory submissions (e.g., NDA/BLA/MAA)
Knowledgeable in AI use in drug development and ambitious in leveraging AI to build infrastructure/workflows to expedite submission process
Excellent organizational skills with the ability to manage multiple priorities
Strong communication and interpersonal skills, with the ability to collaborate cross-functionally
Experience managing CROs and external data vendors
Demonstrated ability to mentor team members and contribute to team development
Advanced knowledge of statistical programming methodologies in clinical study settings
Knowledge of ICH guidelines and FDA / EMA / other regulatory authority requirements
Experience working in a fast-paced, growth-oriented environment
Experience working in a remote/virtual environment
Experience with AI-driven tools or automation in clinical data analysis and regulatory submission processes (e.g., AI-assisted generation, validation, or review of submission deliverables)
Familiarity with modern data platforms, cloud environments, or scalable analytics infrastructure
Experience in a small to mid-size biotech environment
Strong leadership with a collaborative and growth-oriented mindset
High attention to quality and detail
Adaptability and ability to operate effectively in a fast-moving environment
Commitment to fostering a psychologically safe and inclusive team culture
Alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless
Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year

Benefits

Comp & perks

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
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

SAS programmingR programmingCDISC standardsSDTMADaMstatistical programming methodologiesdata review toolsstatistical applicationsautomation in programming workflowsAI in drug development

Soft Skills

leadershiporganizational skillscommunication skillsinterpersonal skillsmentoringcollaborationadaptabilityattention to qualityteam developmentpsychological safety

Certifications

Master's Degree in StatisticsMaster's Degree in BiostatisticsMaster's Degree in MathematicsMaster's Degree in Computer Science