Biostatistics Senior Director - San Francisco - 89Bio

Description

Job Description

Job Description Salary:

THE COMPANY

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.

THE ROLE

Reporting to the Head of Biometrics, the Biostatistics Senior Director 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 Biostatistics Senior Director will contribute strategically to clinical development programs and planning.

SPECIAL ADVISORY

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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 employed
• Evaluates and manages contract research organizations and other vendors, including scope, timelines, and deliverables
• Provides strategic inputs and statistical expertise for clinical development programs. Partners and collaborates with cross-functional leads to meet the regulatory, scientific and business objectives
• Oversees and contributes to the completion of all technical and operational statistical activities through management of internal and external resources
• Negotiates project timelines across programs with competing priorities given constraints. Manages and coordinates limited resources to produce quality deliverables within timelines
• Responsible for ensuring scientific integrity of the statistical methodology applied to clinical trials and rigorous statistical approaches implemented
• Creates, maintains, and implements SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization

THE QUALIFICATIONS

• PhD Degree or equivalent in Statistics, Biostatistics, or related field
• 10 or more years of analytical experience in clinical trials in biotech or pharmaceutical industry
• Extensive hands-on experience in drug development including design and analysis of phase 3 trials and active participation in regulatory filing through label negotiation
• In-depth knowledge of the drug development process as well as knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidance
• Proven effective verbal and written communication skills as well as negotiation and interpersonal skills
• Must have expertise in state-of-the-art data manipulation and statistical analyses
• Proficiency in statistical programming language such as SAS and/or R required
• Proven successful project management leadership skills
• Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems
• Excellent interpersonal skills/ highly collaborative, and ability to cultivate strong internal/external network of relationships
• The ability to anticipate and remediate problems that arise is essential
• Strong analytical problem-solving & interpersonal skills
• Experience with working in high growth, collaborative organizations
• Team oriented, highly motivated, execution focused with strong work ethic, ability to thrive in a high growth, entrepreneurial environment
• Highly adaptable and responsive to technical and business opportunities and needs Comfortable delivering against challenging commitments

SALARY & LEVEL

89bio considers a range of factors when determiningsalary and level. These considerations mean actual salary and level may vary. The expected salary range for this position based on the primary location for this position in Northern California is $265,000 $300,000.

89bios role/level assessment approach involves assessing candidates during the interview process before confirming the level/title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as: education, experience, qualifications, geographic location, transferable skills, licenses/certifications and other job-related factors permitted by law.

THE PERKS

• Competitive health insurance coverage
• Generous PTO allowance
• 401k match
• Employee Stock Purchase Plan (ESPP)
• Commuter Benefits
• Women's forum / mentoring
• Office based in the heart of San Francisco, near plenty of shops and restaurants
• Fun opportunities to engage with co-workers in-person and remotely

CONDITIONS OF EMPLOYMENT

• Background investigations are required for all positions by 89bio, consistent with applicable law.

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.

89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship.

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.