{"id":4053793,"url":"https://alion.io/job/avalotx-senior-manager-biostatistics","title":"Senior Manager, Biostatistics","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":{"grade":"B","score":75,"open_postings":4,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Field & Service","role_family":"Field & Service","seniority":"senior","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":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"SAS","optional":false}],"status":"live","first_seen_at":"2026-06-18T15:14:38Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-13T00:07:21Z","board_verified":true,"closed_at":null,"days_open":147,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":146},"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:\nSenior Manager / Associate Director, Biostatistics to provide strategic and operational statistical leadership across clinical development programs. This individual will serve as the lead biostatistician for one or more clinical development programs and will partner closely with Clinical Development, Medical Affairs, Data Management, Statistical Programming, Regulatory Affairs, and external partners to ensure the delivery of high-quality statistical strategy, analyses, and regulatory submissions.\nThe successful candidate will contribute to study design, protocol development, analysis planning, interpretation of clinical data, regulatory interactions, and evidence generation activities that support development, registration, and lifecycle management of Avalo's programs. This role offers the opportunity to influence development strategy, advance innovative statistical methodologies, and contribute to regulatory and business decision-making across the organization.\nEssential Duties and Responsibilities:\nStatistical Leadership & Clinical Development\nLead the biostatistics strategy for one or more clinical development programs and studies.\nServe as the statistical representative on cross-functional study teams, Clinical Development Teams, and governance committees.\nCollaborate with Clinical Development and Medical teams to design clinical studies aligned with program objectives, regulatory expectations, and business needs.\nProvide strategic input into clinical development plans, including study design, endpoint selection, sample size determination, interim analyses, and decision criteria.\nIdentify potential statistical, operational, or scientific challenges and proactively develop solutions.\nEvaluate and implement innovative statistical methodologies to enhance development strategies and study efficiency.\nSupport quantitative decision-making, including benefit-risk assessments, probability of technical success analyses, and Go/No-Go evaluations.\nStudy Design, Analysis & Reporting\nAuthor and/or review statistical sections of protocols, statistical analysis plans (SAPs), data review plans, and study reports.\nDevelop and/or oversee analysis strategies, including tables, listings, and figures (TLFs), ensuring methodological rigor and regulatory compliance.\nEnsure timely delivery and quality of statistical analyses for interim reviews, final analyses, integrated summaries, and regulatory submissions.\nInterpret study results and effectively communicate findings to technical and non-technical audiences.\nPrepare and review abstracts, posters, manuscripts, presentations, and scientific publications.\nRegulatory & External Interactions\nContribute to regulatory strategies and support global submissions.\nRepresent Biostatistics during interactions with health authorities, including FDA, EMA, PMDA, and other regulatory agencies, as appropriate.\nSupport responses to regulatory questions related to study design, analysis methodologies, and interpretation of results.\nEnsure statistical deliverables meet applicable ICH, FDA, EMA, and other global regulatory requirements.\nMedical Affairs, HEOR & Evidence Generation\nProvide statistical leadership for post-marketing studies, observational research, registry studies, real-world evidence initiatives, and outcomes research activities, as applicable.\nSupport evidence generation strategies that address clinical, scientific, payer, and market access objectives.\nCollaborate with cross-functional partners to identify evidence gaps and develop analytical approaches to address unmet evidence needs.\nContribute statistical expertise to publications, scientific communications, and evidence dissemination activities.\nVendor Oversight & Operational Excellence\nOversee CROs, functional service providers, and external statistical vendors to ensure high-quality deliverables and adherence to timelines.\nCollaborate with Statistical Programming and Data Management to ensure data quality and efficient execution of analyses.\nSupport departmental initiatives focused on process improvement, innovation, quality standards, and inspection readiness.\nContribute to the development and maintenance of statistical standards, procedures, and best practices.\nRequired Education and Experience:\nSr Manager: Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 4 years of pharmaceutical, biotechnology, or clinical research experience; or M.S. with a minimum of 6 years of experience\nAssociate Director: Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 6 years of relevant pharmaceutical industry experience; or M.S. with a minimum of 8 years of experience\nDemonstrated experience providing statistical leadership for clinical development programs and clinical trials.\nStrong knowledge of clinical trial methodology, study design, statistical analysis, and regulatory requirements.\nExperience supporting regulatory submissions and health authority interactions.\nExperience leading cross-functional teams and influencing development strategies.\nExpertise in statistical methods applicable to clinical development, including adaptive designs, longitudinal analyses, survival analyses, and integrated analyses.\nExperience overseeing CROs and external statistical vendors.\nProficiency in SAS and/or R.\nStrong understanding of ICH, FDA, EMA, and other global regulatory guidance.\nExperience with real-world evidence, observational studies, HEOR, or post-marketing research is a plus.\nExperience in immunology, inflammation, autoimmune disease, or related therapeutic areas is preferred.\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":7839,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)","Biotechnology","Financial Services","Health Care"],"lifecycle":[{"event":"open","at":"2026-11-11T03:26:54Z"}],"visa":[],"liveness":{"score":9,"band":"cold","label":"Long shot","p_open":1,"p_active":0.328,"p_room":0.28,"age_days":146,"expected_fill_days":30,"reasons":["conf:0","win:tail","crowd:"],"computed_at":"2026-11-12T10:38:37Z"},"pay":null,"html_url":"https://alion.io/job/avalotx-senior-manager-biostatistics","json_url":"https://alion.io/job/avalotx-senior-manager-biostatistics.json","meta":{"generated_at":"2026-11-13T01:23:51Z","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":3061,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"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-senior-manager-biostatistics"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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-senior-manager-biostatistics"},{"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-senior-manager-biostatistics"},{"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-senior-manager-biostatistics\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Favalotx-senior-manager-biostatistics"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4053793}},{"tool":"search_jobs","arguments":{"company":"avalotx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4053793},"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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