{"id":1414632,"url":"https://alion.io/job/pulmovant-managersenior-manager-statistical-programming-pulmovant","title":"Manager/Senior Manager, Statistical Programming, Pulmovant","company":{"id":685706,"name":"Pulmovant","domain":"pulmovant.com","url":"https://alion.io/company/pulmovant","size_band":"1-10","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":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":74000,"max_usd":149000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":252},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Git","optional":false},{"name":"Python","optional":false},{"name":"SAS","optional":false}],"status":"live","first_seen_at":"2026-09-28T16:57:30Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-14T11:34:51Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape. \nPulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. PHocus met both primary and secondary endpoints including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial. The robust results, in conjunction with mosliciguat’s once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD. These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release here. \nAs part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. \nFor more information, please visit https://www.pulmovant.com. \nAbout Roivant: \nRoivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com. \nPosition: Manager / Senior Manager, Statistical Programming \nSummary: \nPulmovant is seeking a Manager or Senior Manager of Statistical Programming to support the development and delivery of high-quality, submission-ready programming deliverables across our pulmonary/respiratory clinical portfolio. This individual will serve as a lead programmer on clinical studies and regulatory submissions, working closely with Biostatistics, Data Management, Regulatory Affairs, and Clinical Development to ensure that all CDISC-compliant datasets, TLFs, and electronic submission packages meet the highest standards of quality and regulatory compliance. \nKey Duties and Responsibilities \nDevelop, validate, and maintainSAS and R programs to produce CDISC-compliant SDTM and ADaMdatasets, tables, listings, and figures (TLFs) for clinical studies and regulatory submissions \nServe as lead programmer for assigned Phase 2b/3 studies; author and review programming specifications, QC plans, and define.xml files \nEnsure all deliverables are audit-ready and aligned with SAPs, protocols, and applicable FDA/EMA/ICH regulatory guidelines \nContribute to the development and maintenance of reusable SAS macro libraries, R packages, and programming standards to improve efficiency and consistency across programs \nLead or support statistical programming activities for NDA/BLA/IND submissions, including integrated summaries of safety (ISS) and efficacy (ISE), CSRs, and ad hoc regulatory requests \nEnsure compliance with CDISC SDTM/ADaMimplementation guides, FDA Data Standards Catalog, and eCTD submission requirements; author and review Reviewer's Guides and define.xml \nReview and provide input on eCRF designs, external data transfer specifications, central lab/imaging specifications, and protocol deviation plans from a programming perspective \nRepresent Statistical Programming at study team meetings; collaborate with Biostatisticians, Data Management, Medical Writing, Clinical Operations, and Regulatory Affairs to align on timelines and deliverables \nPlan and manage programming timelines and resources across assigned studies; oversee and quality-check deliverables from CROs and external programming vendors \nContribute to or lead development of departmental SOPs, work instructions, and process improvement initiatives related to statistical programming \nMentor junior statistical programmers; providetechnical guidance, code review, and support for professional development \nAt the Senior Manager level, may manage 1-2 direct reports and provide input on hiring, performance, and team-buildingas the function grows \nEducation and Experience \nBachelor's degree in Statistics, Mathematics, Computer Science, or a related field; Master'sdegree preferred \n5-7+ years of statistical programming experience in pharma, biotech, or a CRO (Manager: 5+ years; Senior Manager: 7+ years) \nAdvanced proficiencyin SAS (Base, Macro, STAT, GRAPH) required \nThorough knowledge of CDISC standards (SDTM, ADaM, CDASH) and regulatory submission requirements (FDA eCTD, define.xml, Reviewer's Guides) \nProven experience as lead programmer on at least one late-phase (Phase 2b/3) clinical study and/or regulatory submission \nStrong understanding of GCP, ICH E3/E9 guidelines, and FDA/EMA data submission expectations \nEssential Skills and Abilities \nExcellent attention to detail, communication skills, and ability to manage multiple projects and priorities simultaneously \nProficiencyin R for statistical programming and reporting; familiarity with Python a plus \nExperience supporting NDA/BLA submissions and responding to health authority queries \nFamiliarity with automation tools, version control (Git), and/or cloud-based programming environments \nExposure to real-world evidence (RWE) datasets or adaptive trial designs \nExperience in pulmonary, respiratory, or rare disease therapeutic areas \nSAS certification (Base, Advanced, or Clinical Trials Programming) a plus \nPulmovantprovides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.\nWe will not accept unsolicited resumes noroutreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!","description_format":"text","description_chars":7237,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-28T20:07:16Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":212500,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":73,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.814,"p_room":0.9,"age_days":15,"expected_fill_days":29,"reasons":["conf:4","win:mid"],"computed_at":"2026-10-14T06:34:16Z"},"pay":null,"html_url":"https://alion.io/job/pulmovant-managersenior-manager-statistical-programming-pulmovant","json_url":"https://alion.io/job/pulmovant-managersenior-manager-statistical-programming-pulmovant.json","meta":{"generated_at":"2026-10-14T13:19:55Z","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":16374,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":685706},"rest":"https://alion.io/mcp/rest/get_company?id=685706"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpulmovant-managersenior-manager-statistical-programming-pulmovant"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fpulmovant-managersenior-manager-statistical-programming-pulmovant"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fpulmovant-managersenior-manager-statistical-programming-pulmovant"},{"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/pulmovant-managersenior-manager-statistical-programming-pulmovant\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpulmovant-managersenior-manager-statistical-programming-pulmovant"}]}