{"id":4053794,"url":"https://alion.io/job/avalotx-sr-manager-associate-director-statistical-programming","title":"Sr. Manager/ Associate Director, Statistical Programming","company":{"id":3783009,"name":"AvaloTx","domain":"avalotx.com","url":"https://alion.io/company/world-19","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Field & Service","role_family":"Field & Service","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Chesterbrook, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":9,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CDISC","optional":false},{"name":"SAS","optional":false},{"name":"SQL","optional":false},{"name":"GCP","optional":true}],"status":"live","first_seen_at":"2026-06-18T12:26:43Z","employer_posted_date":"2026-11-09","last_verified_at":"2026-11-11T03:26:54Z","board_verified":true,"closed_at":null,"days_open":145,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":145},"description":"At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process.\nWe share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.\nPosition Summary:\nThe Senior Manager / Associate Director, Statistical Programming will provide strategic and operational leadership for statistical programming activities across one or more clinical development programs. This individual will be responsible for the planning, execution, oversight, and delivery of statistical programming outputs supporting clinical trials, regulatory submissions, publications, and internal decision-making.\nThe successful candidate will serve as a key partner to Biostatistics, Clinical Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and external vendors to ensure high-quality, compliant, and timely programming deliverables. This role offers the opportunity to influence programming standards, mentor team members, and contribute to the continued growth of Avalo’s Biometrics organization.\nEssential Duties and Responsibilities:\nStatistical Programming Leadership\nLead statistical programming activities for one or more clinical studies, programs, or therapeutic areas.\nProvide strategic oversight and accountability for the development, validation, and delivery of statistical programming outputs, including SDTM and ADaM data packages (SDRG, ADRG, Define.xml, submission-ready datasets), and Tables, Listings, Figures (TLFs).\nEnsure programming deliverables meet quality, timeline, regulatory, and audit-readiness requirements.\nSupport regulatory submissions, health authority interactions, publications, and ad hoc analyses.\nVendor and CRO Oversight\nManage and oversee outsourced statistical programming activities conducted by CROs and external partners.\nReview and validate datasets, TLFs, specifications, and programming documentation generated by vendors.\nMonitor vendor performance, timelines, quality metrics, and resource allocation to ensure successful project execution.\nEstablish and maintain effective partnerships with external programming and biometrics vendors.\nCross-Functional Collaboration\nPartner closely with Biostatistics, Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and other stakeholders to deliver high-quality clinical data and analyses.\nReview and provide programming input on Protocols, Statistical Analysis Plans (SAPs), Data Management Plans (DMPs), CRFs, annotated CRFs, data review plans, and dataset and TLF specifications.\nCollaborate on the development of data review tools, dashboards, visualizations, and other statistical applications to support clinical development activities.\nCommunicate programming strategies, timelines, risks, and resource needs to project teams and leadership.\nStandards, Innovation, and Process Improvement\nContribute to the development, implementation, and continuous improvement of internal statistical programming standards, processes, and best practices.\nAssist with establishing framework of programming environment, including library of macros.\nDrive adoption of CDISC standards, programming automation, and innovative analytical solutions.\nMaintain expertise in regulatory requirements, industry standards, and emerging technologies related to statistical programming.\nSupport inspection readiness and represent Statistical Programming during audits and regulatory inspections as needed.\nTeam Leadership and Development\nMentor, coach, and develop junior statistical programmers to support individual growth and organizational success.\nProvide leadership and technical guidance to internal and external programming teams.\nParticipate in recruiting, onboarding, and developing programming talent.\nFoster an inclusive, collaborative, and psychologically safe environment that encourages innovation, learning, and accountability\nRequired Education and Experience:\nMaster's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative discipline. Bachelor's degree with significant relevant experience will also be considered.\nSr Manager: 7+ years of statistical programming experience within the biotechnology, pharmaceutical, or CRO industry; Associate Director: 9+ years of experience\nDemonstrated experience serving as a lead programmer supporting clinical development programs and regulatory submissions.\nAdvanced proficiency in SAS programming, including Base SAS, Stat, Graph, Macro, SQL, and generation of submission-ready deliverables.\nWorking knowledge of R or other modern statistical programming languages is a plus.\nExperience with producing publication-quality statistical graphics using SAS/R is a plus\nExperience with building/contributing to global SAS macro library for TFL generation is highly desirable\nExtensive experience with CDISC standards, including SDTM, ADaM, Define.xml, controlled terminology, and regulatory submission requirements.\nExperience with Pinnacle 21 is a plus\nStrong understanding of ICH guidelines, GCP, FDA, EMA, and other global regulatory requirements.\nExperience managing external CROs, FSPs, or programming vendors.\nExcellent project management, organizational, communication, and stakeholder management skills.\nPreferred\nExperience supporting multiple clinical programs from early development through regulatory submission.\nExperience implementing programming standards, automation initiatives, or modern analytics platforms.\nAbout Avalo Therapeutics\nAvalo Therapeutics is a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases. Avalo is advancing its lead anti-IL-1β monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1-4% of the population globally. Avalo is pursuing additional development opportunities in IL-1β driven indications. Avalo is also developing AVTX-010, a long-acting next-generation anti-IL-1β mAb. For more information about Avalo, please visit www.avalotx.com.\nATTENTION: External Agencies and Placement Firms\nA member of the Avalo Human Resources Department will contact an agency directly if an open position is eligible to be sourced from an outside recruiting service. Avalo does not accept unsolicited resumes from employment agencies for any employment opportunity. All agencies/recruiters must have a written agreement/SOW in place with Avalo and prior to submitting any resume or CV.\nAll resumes must be submitted through the appropriate process. Any resumes submitted without an agreement and/or any resumes sent unsolicited through e-mail accounts of Avalo employees will be considered outside of the appropriate process, do not imply or create any obligation on our part, do not impart any restrictions on Avalo with respect to the hiring of any persons whose resumes are so submitted and are not eligible for placement fees.","description_format":"text","description_chars":7521,"description_truncated":false,"requirements":{"experience_years_min":9,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Financial Services","Health Care"],"lifecycle":[{"event":"open","at":"2026-11-11T03:26:54Z"}],"visa":[],"liveness":{"score":10,"band":"cold","label":"Long shot","p_open":1,"p_active":0.371,"p_room":0.28,"age_days":145,"expected_fill_days":29,"reasons":["conf:1","win:tail","crowd:"],"computed_at":"2026-11-11T04:42:54Z"},"pay":null,"html_url":"https://alion.io/job/avalotx-sr-manager-associate-director-statistical-programming","json_url":"https://alion.io/job/avalotx-sr-manager-associate-director-statistical-programming.json","meta":{"generated_at":"2026-11-11T04:42:54Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":5497,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":3783009},"rest":"https://alion.io/mcp/rest/get_company?id=3783009"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Favalotx-sr-manager-associate-director-statistical-programming"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Favalotx-sr-manager-associate-director-statistical-programming"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Favalotx-sr-manager-associate-director-statistical-programming"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/avalotx-sr-manager-associate-director-statistical-programming\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Favalotx-sr-manager-associate-director-statistical-programming"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4053794}},{"tool":"search_jobs","arguments":{"company":"avalotx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4053794},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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