Associate Director of Statistical Programming

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 

The Associate Director of Statistical Programming leads statistical programming activities at the study or project level. Responsible for performing the programming and statistical analyses necessary to analyze the results of clinical trials and ad-hoc requests for regulatory submission, publications or related activities. Manages CROs and contractors with regarding the compliance, deliverable qualities and timelines. Leads global submission activities. 

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  

• Validate/crosscheck the relevance and accuracy of the SDTM and ADAM datasets and the resulting Tables, Listings and Graphs (TLGs) developed by Clinical Research Organizations (CROs). 

• Manages, reviews and/or executes statistical programming deliverables for planned statistical analysis, related to study monitoring, clinical study reports, data integrations and regulatory query responses, covering multiple compounds and studies. 

• Leads global submission activities including cross company projects. Acts as a programming functional and technical expert to support submission strategy planning, regulatory communication. 

• Able to produce timely statistical analyses of clinical and related data analysis per protocols and SAPs. Able to develop statistical programs and produce programmed outputs used to create integrated scientific reports for clinical trial results. 

• Participates in the development and maintenance of internal SAS macro library and safety data review. 

• Provides statistical input for Statistical Analysis Plans (SAPs), publication activities, scientific presentations, and regulatory submissions. 

• Participates in the review of Case Report Forms (CRFs), CRF annotations, SAPs, and TLGs shells and TLGs. 

• Participates in study team meetings as an Indication lead of the statistical programming function. Communicates statistical issues and acts as a statistical/programming resource to the development teams. 

THE QUALIFICATIONS 

• Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 10 years in statistics or statistical programming in a biotech/pharmaceutical or CRO environment. 

• Bachelor’s degree in quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 12 years in statistics or statistical programming in a biotech/pharmaceutical or CRO environment. 

• Experience with CRO oversight. 

• Experience in lead programming activities involving CDISC SDTM, ADaM, generation of TFLs. 

• Regulatory submission experiences. Have lead programming activities involving CDISC SDTM, ADaM, preparing submission documentations. 

• Excellent SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems. 

• Excellent interpersonal and communication skills. 

• Good organizational skills with the ability to adapt and adjust to changing priorities. 

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 $160,000 – $180,000.  

89bio’s 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, 89bo 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. 

Salary : $160,000 - $180,000