Senior Director, Statistical Programming

Senior Director, Statistical Programming RemoteAbout Apogee TherapeuticsFounded in 2022, Apogee Therapeutics, Inc. is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company's most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care.We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at "good enough".If this sounds like you, keep reading!Role SummarySupport the statistical programming function by implementing programming processes, standards, and SOPs for clinical trialsContribute to the development and maintenance of SAS programming infrastructure, processes, and data standardsLead programming activities for assigned projects and studies (e.g. leading submission), ensuring timely and high-quality deliverablesManage and oversee CROs and external vendors to ensure quality and compliance with expectationsCollaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functionsDevelop and implement data review, reporting tools, and statistical applications in partnership with cross-functional teamsReview and validate SAS programs (SDTM, ADaM, and TFLs) generated internally or by CROsReview SAPs, DMPs, CRFs, annotated CRFs, TFL specifications, and other study documents, providing expert programming inputMentor and develop programmers, fostering a high-performing and collaborative team environmentProvide hands-on support for complex analyses and ad hoc requests as neededDrive process improvements and efficiencies, including the adoption of automation and AI-based solutions in programming workflowsIdeal CandidateMaster's Degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related fieldA minimum of 12–15 years of progressive clinical trial programming experience in the biotech/pharma industry, including leadership experienceAdvanced SAS programming skills: experience with R or other statistical programming languages preferredStrong experience and in-depth knowledge of CDISC standards (SDTM, ADaM) and controlled terminologyExperience 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 processExcellent organizational skills with the ability to manage multiple prioritiesStrong communication and interpersonal skills, with the ability to collaborate cross-functionallyExperience managing CROs and external data vendorsDemonstrated ability to mentor team members and contribute to team developmentAdvanced knowledge of statistical programming methodologies in clinical study settingsKnowledge of ICH guidelines and FDA / EMA / other regulatory authority requirementsExperience working in a fast-paced, growth-oriented environmentExperience working in a remote/virtual environmentExperience 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 infrastructureExperience in a small to mid-size biotech environmentStrong leadership with a collaborative and growth-oriented mindsetHigh attention to quality and detailAdaptability and ability to operate effectively in a fast-moving environmentCommitment to fostering a psychologically safe and inclusive team cultureAlignment with Apogee's C.O.R.E. values: Caring, Original, Resilient, and EgolessPosition requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco officeThe anticipated salary range for candidates for this role will be $270,000 - $295,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.What We OfferA great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and EgolessOpportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quicklyMarket competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefitsWe provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leaveCommitment to growing you professionally and providing access to resources to further your developmentApogee offers regular all team, in-person meetings to build relationships and problem solveE-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.