{"id":2775240,"url":"https://alion.io/job/alvotech-director-statistical-programming","title":"Director, Statistical Programming","company":{"id":2394553,"name":"Alvotech","domain":"alvotech.com","url":"https://alion.io/company/alvotech","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"HR","role_family":"HR","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Stockholm, Sweden","Sweden"],"countries":["SE"],"hiring_countries":["SE"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":68000,"max_usd":173000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1542},"experience_years_min":15,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"SAS","optional":false}],"status":"live","first_seen_at":"2026-10-16T00:00:00Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-17T12:25:50Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Job Title: Director,Statisticaland Data ManagementProgramming\nAbouttheDepartment/Company\nAlvotech is a fully integrated specialty biopharmaceutical company focused exclusively ondevelopmentand manufacturing of high-quality biosimilar medicines.\nWithin Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities.\niCMRis launching an ambitious and exciting project aimed at modernizing andoptimizingthe departmental operating model. As part of this project, we are recruiting for the following position:\nOverview ofJobRole\nTheDirector ofStatisticaland Data ManagementProgrammingwillberesponsible forestablishing,leadingand advancing statistical programmingandData Management (DM)programmingactivitiesforbiosimilarstudies,ensuring high-quality andtimelydeliverables.They will provide strategic leadership and support the vision of both Statistical andDMprogrammingfunctionsthrough the establishment of robust programming capabilities, processes, standards, and quality frameworks.In addition, this role requires a hands-on approach, particularly during the build-out and maturation of the function, with direct involvement in programming activities, deliverable development, process implementation, and technical oversight.\nScopeandresponsibility\nDevelop and guide the strategy for programming activities, ensuring adherence to standards and processes.\n\nServe asfunctionalexpert and senior advisor for data standards, programming methodologies, and submission strategies.\n\nContribute todevelopingand updatingcompany-wideStandard Operating Procedures (SOPs) forDMandstatisticalprogramming.\n\nEstablish andmaintainprogramming standards, validation procedures, and reusable code libraries.\n\nDrive efficiency through standardization, automation, and innovative programming solutions.\n\nPartner with Biostatistics,DM, and otherclinical studyteams to align analysis and reporting deliverables.\n\nDevelop andvalidateprogramming code to supportdata cleaningdiscrepanciesand reconciliationoutputs, in collaboration withDM\n\nPerform and overseeprogramming ofSDTM andADaMdatasets, Tables, Listings, Figures (TLFs), and submission-readypackages (includingannotatedCase Report Form,Pinnacle21 checks,Define.xml and Reviewers guides).\n\nEnsure regulatory compliance with ICH-GCP, CDISC standards, FDA, EMA, and other global regulatory requirements.\n\nMaintain inspection and audit readiness.\n\nCoach, mentor, and develop direct reports, ensuring training compliance andparticipatingin the hiring process.\n\nSupport resource forecasts tooptimizeproject allocation and manage resourceutilizationeffectively.\n\nJobrequirements\nMaster’sdegreeor equivalent with15+ years of relevant experience.\n\n10+years of experience in Statistical Programming within the pharmaceutical industry including leadershipand peoplemanagement responsibilities.\n\nExtensive experience in the life sciences sector with a strong understanding of drug development processes.\n\nDeep knowledge ofregulatory requirementsrelated tostatistical programming, validation, and data governance.\n\nExpert-level understandingand practical knowledgeof CDASH, SDTM,ADaM, and CDISC controlled Terminology standards.\n\nAdvancedexpertisein SAS programming(proficiencyin otherlanguageis a plus), relational database structures, and data workflow.\n\nExperience supporting global regulatory submissions (FDA, EMA, PMDA).\n\nExcellent project management skills and ability to handle multiple projectssimultaneously.\n\nAble to work in cross-functionaland internationalteam.\n\nStrong leadership, communication, and interpersonal skills.\n\nFull workingproficiencyin English.","description_format":"text","description_chars":3828,"description_truncated":false,"requirements":{"experience_years_min":15,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Sweden","iso":"SE","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-10-17T08:34:05Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring 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