Manager, Biostatistics and Regulatory Platform Owner
General Scope and Summary
Sage is searching for a results-oriented and collaborative technology leader as the Platforms owner for Biostatistics and Regulatory. The role will be responsible for leading new capability build ups, operationalizing Platform capabilities and scaling them in partnership with key business partners in R&D business functions. The Platform owner will serve as an expert technical leader and Systems SME to collaborate with R&D functional leads.
This role will be part of the team working on streamlining, automating and enhancing Biostatistics and Regulatory platforms to provide the insights required to orchestrate many strategic partners in delivering solutions for brain disorders.
Roles and Responsibilities
Partner with stakeholders throughout full lifecycle of data sciences, regulatory and safety systems integration – from defining business need, project planning, requirements management, vendor selection, development, deployment, and end user adoption – and provide ongoing management and functional oversight for all electronic development systems.
Lead, partner and direct external service providers.
Serve as the platform owner of the Biostatistics, Regulatory and Drug Safety/Pharmacovigilance technologies.
Analyze business processes, propose solutions for current and future needs, and assist in implementing recommended improvements, in accordance with Sage operating standards.
Assure system is properly implemented according to business requirements and FDA Part 11 requirements. Ensure systems maintain GxP validated state, including preparation of documentation, execution of testing, management of user access, and coordinating change management and related processes.
Develop and manage system documentation including, but not limited to, user requirement specifications, configuration specifications, user acceptance testing plans, SOPs, and validation records.
Collaborate with users to establish operational workflows and transform the workflows into system configuration.
Work with functional leaders to align on key measures and metrics for success.
Oversee the creation and customization of program- and department-level analytical reports and dashboards to support a data-driven operating model.
Lead ad-hoc analytical projects.
Develop and maintain internal data repositories, as needed.
Drive innovation and the delivery of continuous process improvement.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Excellent interpersonal skills including conflict management and stakeholder management
Bachelor’s degree required (scientific or technical discipline)
5+ years of experience working in the biopharma environment managing R&D development systems (for example, clinical data analytics, Veeva platforms, RIM technologies, PV/safety systems such as Argus, data science platforms such as SAS), underlying processes, and data.
At least one GxP system implementation
Experience with Veeva Vault and Veeva Vault configuration. Veeva Certified Administrator a plus
Experience in developing business specifications/requirements and user acceptance testing for computer systems.
Experience with vendor management and oversight of data exchange, migration and integration.
Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects, both working independently and within a team.
Flexibility to adapt to the dynamic needs of a growing biotech company and to manage change effectively.
Ability to learn quickly and adjust approach to problems based on feedback.
Strong team player that has a customer service approach and is solution oriented.
Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of SAGE.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.