What are the responsibilities and job description for the Senior Director, Biostatistics position at 89Bio?
Job Description
Job Description
Salary : $285,000 $298,000 yr
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 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 ADVISORY
The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, 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 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
10 or more years of analytical experience in clinical trials in biotech or pharmaceutical industry
Proficiency in statistical programming language such as SAS and / or R required
SALARY & LEVEL
89bio considers a range of factors when determining salary 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 $285,000 $298,000.
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
CONDITIONS OF EMPLOYMENT
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.
Salary : $285,000 - $298,000
