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. We are seeking a highly motivated individual to join Soleno Therapeutics as a Senior Manager/Associate Director of Biostatistics. The Sr. Mgr/Associate Director of Biostatistics will work with a dedication to serving colleagues and cross-functional teams on the design, analysis, and reporting of clinical studies; plan and conduct sophisticated statistical analyses in defense of regulatory submissions; and support the company’s external publications and corporate objectives.

Responsibilities

• Contribute to innovative study design and protocol development, including sample size estimation, formulation of statistical hypotheses and testing strategy, and statistical methods.
• Implement clinical studies by writing statistical sections of study protocols and statistical analysis plans, TFL shells, and efficacy results sections of CSRs. Provide statistical insight into the interpretation and discussion of results.
• Provide statistical support for regulatory meetings, submissions, and regulatory defense. Be well versed with details of studies and analyses conducted.
• Maintain statistical expertise by learning new methodologies, choosing which methods to use in analysis, and justifying methods selected. Understanding of analysis methods related to observational data and realworld evidence.
• Collaborate with statistical programming to establish analysis expectations, scope of validation, and timelines. Conduct statistical review of programming deliverables.
• Build effective partnerships with colleagues in the clinical, regulatory, and payer/ commercial areas. Develop and maintain understanding of disease areas for enhanced collaboration.
• Input into CRF and database design, particularly efficacy data collection and validation. Drive cross-functional data review, preparation of special outputs if necessary. Carefully plan dissemination of blinded data during the study and topline and final results after unblinding.
• Oversee statistical contractors/consultants and manage or mentor junior team members.

Qualifications

• PhD in Statistics with 4 years of experience working in clinical development in a pharmaceutical, biotechnology, or CRO industry environment or an MS in Statistics with 6 years of experience.
• Excellent verbal and written communication skills; ability to work in a team environment with medical personnel, clinical monitors, programmers, data managers and medical writers. Attention to detail is required.
• Knowledge of FDA/ICH guidelines. Experience with preparation of briefing documents, and responses to questions from regulatory agencies is preferred.
• Understanding of advanced statistical concepts and techniques.
• Familiarity with a wide range of trials used in rare diseases like observational studies, RWD, basket trials in addition to traditional clinical trials.
• Ability to manage multiple priorities and quickly navigate ambiguity.
• Proficiency in the use of statistical software (eg: SAS, R, JMP, etc.) and in sample size estimation.
• Ability to be flexible and adapt quickly to the changing needs of the organization.

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.)