{"id":3007300,"url":"https://alion.io/job/prokidney-sr-director-biostatistics","title":"Sr. Director, Biostatistics","company":{"id":7427,"name":"ProKidney","domain":"prokidney.com","url":"https://alion.io/company/prokidney","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":172000,"max_usd":295000,"period":"year","method":"global_role_seniority_cell","sample_n":507},"experience_years_min":10,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false},{"name":"Python","optional":false},{"name":"SAS","optional":false}],"status":"live","first_seen_at":"2026-08-19T16:14:22Z","employer_posted_date":"2026-08-19","last_verified_at":"2026-11-01T02:49:30Z","board_verified":true,"closed_at":null,"days_open":73,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":73},"description":"Position Summary:\nProKidney is seeking a Senior Director, Biostatistics to serve as the statistical lead for its pivotal Phase 3 program. This highly visible, hands-on role requires a technically strong statistician who can operate strategically while remaining close to the work.\nThe Senior Director will lead statistical strategy, analysis, interpretation, and reporting for complex clinical trial data, while supporting regulatory interactions, topline readout, and future submission activities. The ideal candidate will bring deep statistical expertise, strong drug development judgment, FDA-facing experience, and the ability to collaborate effectively across clinical development, regulatory, data management, data science, pharmacovigilance, quality, and executive leadership.\nEssential Duties & Responsibilities:\n Phase 3 study lead; accountable for not only study read out but all biostatistics elements that will subsequently feed into a BLA, such as the integrated safety summary.\nProvide hands-on statistical leadership for study design, statistical analysis plans, data interpretation, reporting, and regulatory deliverables.\nKey member of the cross functional core study team who represents the interests of the biostatistics deliverables while overseeing the overall study conduct.\nEscalation point and oversight of all external vendors, such as WCG for the Endpoint Adjudication committee and Icon for Central Laboratory\nFunctional lead of the biostatistical team\nLeader who maintains composure and creative problem solving in a flexible, fast paced\nAccountable author of the statistical analysis plan, tables listings and figures shells, and subsequent documentation\nProvide statistical leadership for complex issues including randomized versus treated populations\nLeads trial design, protocol development, analysis planning, interpretation of results and preparation of regulatory submissions\nGenerates statistical models to improve methods of evaluating quantitative and qualitative data, identifying relationships and trends in data and factors affecting research results.\nSupport FDA-facing discussions and help advocate for appropriate analytical approaches in a complex and differentiated therapeutic setting.\nProvides ad hoc data driven analyses\nIndependently research, propose, teach and implement advanced statistical analyses\nAccountable and responsible for biostatistics SOP development and maintenance\nContribute to executive-level program updates, including biweekly interactions with senior leadership regarding study progress, key risks, upcoming milestones, and decision points.\nMinimum Qualifications:\n Education/Training:\nAdvanced degree in Statistics, Biostatistics, Mathematics, or related Ph.D. preferred.\nMinimum of 10 years of pharmaceutical and/or biopharma industry experience, including design and analysis of clinical studies (cell therapies/biologics a plus).\nFormal education in statistics, biostatistics or the mathematical sciences\nExperience leading and reading out late stage programs\nBroad clinical trial expertise\nMust have strong statistical academic background, knowledge of quantitative methods including predictive modeling techniques.\nProficiency in SAS, R, Python or related data analysis languages\nExperience with study design and data analysis from a range of different phases of clinical development.\nPrior experience with studies involving nontraditional treatment logistics,\nPrior involvement in BLA/NDA submission planning and execution.\nProficiency with Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint).\nMust have excellent interpersonal, communication, writing and organizational\nMust have excellent analytical skills in order to filter, prioritize and validate potentially complex and dynamic material from multiple sources.\nProven ability to meet strict\nExcellent organizational skills and time management\nExcellent attention to detail and accuracy maintaining consistently high-quality\nSelf-motivated and\nAbility to establish and maintain effective working relationships with coworkers, managers and clients.\nProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\nApplicants must be eligible to work in the United States without the need for work visa or residency sponsorship.","description_format":"text","description_chars":4574,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)","Cell & Gene Therapy","Regenerative Medicine"],"lifecycle":[{"event":"open","at":"2026-10-21T14:15:12Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":2,"green_card_filings_12m":0,"median_offered_wage_usd":107500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA 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