Senior Director, Biostatistics
89bio - San Francisco, CA
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THE COMPANY 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The companys lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). THE ROLEReporting to the Head of Biometrics, the Senior Director of Biostatistics is responsible for biostatistics tasks for all phases of clinical trials including oversight of CRO biostatistics activities and supporting other functional areas such as programming, data management, clinical development and regulatory. The Senior Director of Biostatistics will contribute strategically to clinical development programs and planning.SPECIAL ADVISORYThe FTC has an advisory out on the domain if you are contacted by any group using a similar, but not our exact domain , please Report any Scams.THE RESPONSIBILITIES Applies statistical principles and appropriate statistical methodology to align with health authority guidelines and meet regulatory requirements. Ensures proper statistical approaches for the design and analysis of clinical studies are employedEvaluates and manages contract research organizations and other vendors, including scope, timelines, and deliverablesProvides strategic inputs and statistical expertise for clinical development programs. Partners and collaborates with cross-functional leads to meet the regulatory, scientific and business objectivesOversees and contributes to the completion of all technical and operational statistical activities through management of internal and external resourcesNegotiates project timelines across programs with competing priorities given constraints. Manages and coordinates limited resources to produce quality deliverables within timelinesResponsible for ensuring scientific integrity of the statistical methodology applied to clinical trials and rigorous statistical approaches implementedCreates, maintains, and implements SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimizationTHE QUALIFICATIONSPhD Degree or equivalent in Statistics, Biostatistics, or related field10 or more years of analytical experience in clinical trials in biotech or pharmaceutical industryExtensive hands-on experience in drug development including design and analysis of phase 3 trials and active participation in regulatory filing through label negotiationIn-depth knowledge of the drug development process as well as knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidanceProven effective verbal and written communication skills as well as negotiation and interpersonal skillsMust have expertise in state-of-the-art data manipulation and statistical analysesProficiency in statistical programming language such as SAS and/or R requiredProven successful project management leadership skillsExpert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problemsExcellent interpersonal skills/ highly collaborative, and ability to cultivate strong internal/external network of relationshipsThe ability to anticipate and remediate problems that arise is essentialStrong analytical problem-solving & interpersonal skillsExperience with working in high growth, collaborative organizationsTeam oriented, highly motivated, execution focused with strong work ethic, ability to thrive in a high growth, entrepreneurial environmentHighly adaptable and responsive to technical and business opportunities and needs - Comfortable delivering against challenging commitmentsSALARY & LEVEL89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary. The salary range for this position is $285,000 - $298,000 and will be commensurate with experience. THE PERKS Competitive health insurance coverageGenerous PTO allowance401k matchEmployee Stock Purchase Plan (ESPP)Commuter BenefitsWomens forum / mentoringOffice based in the heart of San Francisco, near plenty of shops and restaurantsFun opportunities to engage with co-workers in-person and remotely All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Proof of Covid vaccination is a condition of employment. Notice to Recruiters:To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.
Created: 2024-10-16