Senior Director, Biostatistics

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 company's 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 ROLE

Reporting 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.

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 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 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.

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.