{"id":3965523,"url":"https://alion.io/job/sobi-senior-statistical-scientist","title":"Senior Statistical Scientist","company":{"id":4965,"name":"Sobi","domain":"sobi.com","url":"https://alion.io/company/sobi","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Basel, Switzerland"],"countries":["CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"SAS","optional":false},{"name":"CDISC","optional":true}],"status":"live","first_seen_at":"2026-11-09T11:36:32Z","employer_posted_date":"2026-11-09","last_verified_at":"2026-11-10T00:23:00Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.\nSenior Statistical Scientists provide experienced statistical, scientific and strategic support across assigned studies or indications. The role is differentiated from Statistical Scientist by broader responsibility and increased independence.\nThe Senior Statistical Scientist is typically taking the role as Study Statistician for multiple, complex or business critical studies, but may also work as a Program Statistician or in other roles as appropriate.\n Key Responsibilities\nThe Study Statistician:\nis responsible for the overall quality and the timely delivery of the statistical analyses for assigned studies in compliance with Sobi SOPs and regulatory requirements/guidelines\nprovides leadership and oversight to in-house consultants and CRO statisticians working on the assigned studies.\nsupports the Program or Product Statistician in study design to meet project objectives and regulatory requirements\nDevelops or oversees the Statistical Analysis Plans (SAPs) and study-level statistical deliverables.\nProvides statistical input to study protocols, CRFs TFL shells or prototypes.\nEnsures that study result interpretation, presentations and CSR conclusions are scientifically justified by the study results.\nProvides programming support for in-house reporting, simulations and exploratory analyses as appropriate.\nContributes to CSRs, regulatory question responses, publications and abstracts.\nStays informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings.\nThe Program Statistician:\nsupports the Product Statistician in study design for the program or indication to meet project objectives and regulatory requirements\nis responsible for the overall quality and the timely delivery of the statistical analyses for the studies within the assigned indication or program in compliance with Sobi SOPs and regulatory requirements/guidelines\nProvides statistical and strategic input into the design and preparation of Clinical Development Plan for the assigned program, ensuring alignment with TPPs and Target Label.\nContributes to regulatory submission documents for the assigned indications, including eCTD content, responses to regulatory questions and other relevant documents.\nprovides leadership and project coordination to the statisticians working in the program, including in-house consultants and statisticians at CROs\nScope of the Job\nStudy Statistician:\nprovides leadership to in-house consultants and CRO statisticians working on the assigned studies.\nsupports the Program or Product Statistician in study design to meet project objectives and regulatory requirements\nDevelops Statistical Analysis Plans and study-level statistical deliverables.\nProvides statistical input to study protocols, Statistical Analysis Plans, CRFs and TFL shells or prototypes.\nEnsures that study result interpretation, presentations and CSR conclusions are scientifically justified by the study results.\nProvides programming support for in-house reporting, simulations and exploratory analyses as appropriate.\nContributes to CSRs, regulatory question responses, publications and abstracts as delegated.\nContributes to CRO evaluation, best-practice development, new initiatives and SOP development as relevant.\nStays informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings.\nProgram Statistician:\nProvide leadership and project coordination to the statisticians working in the program, including in-house consultants and statisticians at CRO\nProvide statistical and strategic input into the design and preparation of the Clinical Development Plan (CDP) for the assigned program ensuring alignment with the TPPs and Target Label\nProvide statistical and strategic input to relevant regulatory documents for the assigned program, e.g. eCTD responses to regulatory questions.\nProvide statistical and strategic input into other regulatory documentation for the assigned program e.g., IB, PSUR and RMP\nTake a pro-active role in designing innovative studies and programs, including Go/No Go criterion and associated risk levels, to meet project objectives\nContribute to the writing of publications and abstracts, in accordance with the publication strategy for the project\nStay informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings.\nContribute to the development of SOPs as relevant\nEducation/Learning Experience\nRequired: Bachelor of Science (BSc) in mathematical statistics, statistics or equivalent.\nDesired: Master of Science (MSc) or PhD in mathematical statistics, statistics or equivalent\nWork Experience\nRequired:\nMinimum of 5 years of experience as a statistician in the pharmaceutical industry, CRO or related field.\nPrevious experience of working as a study statistician or equivalent\nExperience working in more than one phase of clinical development\nExperience of statistical programming in SAS; experience with R or other statistical software is desirable.\nDesired:\nExperience of regulatory submission and defense activities\nExperience of regulatory interactions\nExperience of clinical program and study design and data analysis in using a variety of designs and statistical techniques\nExperience of collaboration with statisticians and other functions at CROs in the area of out-sourced clinical studies\nSkills/Knowledge\nRequired: \nComprehensive knowledge of clinical and pharmaceutical drug development\nSound knowledge of theoretical and applied statistics\nAbility to find innovative approaches to trial design and analysis\nSound understanding of the regulatory environment within clinical development\nAbility to be the statistical representative from the company at regulatory interactions\nAbility to coach less experienced statisticians in all aspects of their role.\nDesired: \nGood understanding of CDISC, including SDTM and ADaM\nPersonal Attributes\nRequired: \nExcellent written and oral communication skills\nStrategic thinking and influencing skills\nAbility to communicate statistical information to non-statisticians\nStrong ability to collaborate and contribute in global cross-functional teams\nLeadership skills\nLanguages\nRequired: \nExcellent writing and oral communication in English","description_format":"text","description_chars":6781,"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":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Switzerland","iso":"CH","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & 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