VP, Data Sciences (Clinical) - Seaport Therapeutics

VP, Data Sciences 

Seaport Therapeutics is seeking someone to lead their data science team.  Reporting to the Chief Medical Officer, the Vice President, Data Sciences to build and lead the Biostatistics, Statistical Programming and Clinical Data Management functions to support our Portfolio.    This leader will help to provide strategic direction, design, and analysis of clinical and translational studies for the evaluation, interpretation and preparation of study results.

Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs.   The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph^TM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit www.seaporttx.com

The Vice President, Data Sciences will lead a group of biostatisticians, statistical programmers, clinical data management, and data analyst professionals who develop, implement, and execute across the following broad areas of responsibility:

• Drive and provide critical guidance and input into the design of clinical studies and assembly of clinical trial protocols and statistical analysis plans for clinical trials, as well as for key sections of license applications 
• Oversee the biostatistical analysis of clinical trials
• Provide strategic guidance in the preparation of Regulatory Authority documents such as clinical study reports, submissions, clinical protocols, aggregate safety, and clinical pharmacology reports
• Ensure the interpretation of accurate and scientifically credible clinical and scientific data obtained from our clinical trials is appropriately presented internally and to Health Authorities and healthcare providers
• Provide statistical support and expertise to internal cross functional teams to generate study reports, posters, publications, and data/results dossiers for submission to regulatory authorities
• Identify risks to trial design and reporting and develop solution-orientated approaches to address or mitigate risk
• Partner closely with Translational Medicine Group and Technical Operations to develop the appropriate workflows and mechanisms for data transfer from external vendors, with an emphasis on data integrity

Required Experience & Qualifications

• PhD or MS in statistics or biostatistics with 15+ years of experience in the pharmaceutical and/or biotechnology industry and at least 8 years of direct management experience
• Broad and extensive knowledge of theoretical and applied statistics
• CNS experience preferred
• Expert in the principles and techniques of data analysis and interpretation necessary for global registrational filings (e.g. development of Clinical Study Reports, integrated summaries, etc.)
• Extensive regulatory experience with gaining approvals of NDAs, MAAs, BLAs
• Proven experience in building and managing a high performing team in a dynamic environment; recruitment, motivation and empowerment by leading and collaborating with cross-functionality and efficient delegation
• Expert level experience with SAS and/or other statistical software packages
• Demonstrated ability to establish relationships with internal colleagues and external collaborators and represent the company in public settings
• Proficient with GCP/ICH/FDA requirements, clinical trial design and strategies
• Must have a results-oriented work ethic and a positive, can-do attitude
• Proven track record of working with cross functional teams and external vendors/partners
• The ideal candidate will be capable working in a "hands on" and "roll-up sleeves" capacity when required or providing oversight and guidance depending on the circumstances