Senior Manager/Associate Director, Biostatistics

About Soleno Therapeutics Inc

Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are – it is in our chromosomes – and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS. 

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way. 

Our employees are our greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impact—and making history. We all share the most important goal of bringing solutions to the PWS community. 

Summary of Job (brief description)

Soleno Therapeutics, Inc., based in Redwood City, California, is a clinicalstage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases. The Senior Manager of Statistical Programming performs hands-on programming for individual clinical studies and pooled data. We are looking for a technically strong SAS programmer who can provide CDISC dataset specifications, program datasets, and individual outputs.

Responsibilities

• Provide hands-on programming for individual study and pooled analyses conducted in-house •
• Provide input into various study documents like the SAP, DMP, DVP, DTS.
• Working knowledge of CDISC standards. Prepare SDTM and ADaM dataset specifications. Program datasets.
• Write programs to implement statistical plans for new studies or slight modifications of previously run analyses. Self-check programs by understanding interdependencies in the data or comparing with previously obtained results.
• Identify and communicate data issues encountered during stat deliverable programming to the appropriate parties.
• Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods.
• Work with urgency on responses to regulatory queries in collaboration with other statistical and programming colleagues.
• Contribute to the maintenance of the statistical computing environment to support global usage.
• Complete additional tasks and/or activities as requested and/or required to communicate results.
• Ensure the successful achievement of department and company goals.

Qualifications

• Master’s degree in Statistics or quantitative discipline with 6+ years of relevant Pharmaceutical/Biotech/CRO Industry clinical statistical analysis/programming experience or Bachelor’s degree with 8+ years.
• Strong knowledge of Base SAS, SAS/STAT, SAS macros, and SAS/GRAPH. Proficiency in quick visualization tools like Spotfire and JMP.
• Ability to communicate effectively both cross-functionally and within the programming function.
• Practical experience with CDISC standards such as CDASH, SDTM, ADaM, and Define-XML. Practical experience with validation software for standardized data (e.g. Pinnacle 21).
• Integrated Summary Safety / Efficacy Analyses+ Safety data and Coding Dictionaries –understanding of pooling practices.
• Good understanding of protocol design, study conduct, and clinical data flow.
• Interpersonal/teamwork skills for effective interactions.
• Project planning skills – ability to set timelines and intermediate milestones to track progress.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Work with external vendors and third-party organizations and provide oversight to outsourced work.

Salary Range: $160,000 - $220,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)