Hr director Jobs in Chula Vista, CA

DescriptionVentyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases.The Opportunity : Director / Senior Director, Biostatistics : The Director / Senior Director, Biostatistics is responsible for providing strategic, scientific, and statistical leadership to the assigned clinical development programs. This position oversees statistical aspects ensuring programs meet scientific, regulatory, and quality requirements and are aligned with long-term development goals, through interactions with leadership and members of functions (e.g., Clinical Development, Clinical Operations, Regulatory Affairs). This role will provide hands-on support for study design, statistical analysis, and reporting of data and will plan, organize, coordinate, and review biostatistics activities for assigned projects. This individual will coordinate with other functional groups to ensure timeliness and quality of project deliverables and create best practices in accordance with Good Clinical Practices (GCP) for the Biometrics function. This individual will contribute to development strategies aligned to organizational goals, including innovative and relevant statistical designs, statistical expertise for regulatory documents and for key decisions, and scientific communications. This position reports to the SVP, Biometrics and Data Management.What You Will Contribute : Provides statistical expertise to new drug development programs as a Subject Matter Expert in Biostatistics.Provides statistical leadership in the design of clinical development plans.Be the statistical leader and project manager accountable for all Biometrics deliverables for assigned projects.Be a thought leader and expert in statistics providing leadership and hands on expertise in statistical methods, regulatory guidelines (FDA, EMA, ICH, etc.), program strategies, clinical development planning and study designs in multiple autoimmune and inflammatory indications.Represent the Biostatistics and Programming functions to ensure coordination and alignment across Biometrics functions on program strategies and deliverables.Ensure the quality of statistical input and show the ability to integrate expertise across Biostatistics components internally and externally.Accountable for production of the following study-related deliverables : appropriate sections of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and other registration documents.Accountable for team’s statistical support aspects of assigned therapeutic areas including experimental design, protocol development, sample size estimation, statistical analysis plan development, patient randomization, case report form design, statistical analyses, and presentation of data.Directs and conducts statistical analyses and interprets results of analyses for assigned studies.Ensure the team maintains consistent analytical approaches and reporting formats within and across studies.Accountable for the accuracy and completeness of statistical analyses.Researches and applies new statistical procedures as needed. Initiate and drive innovation by implementing innovative and relevant designs in the support of program strategy.Establishes and maintains effective working relationships with vendors, internal coworkers, and project teams.Oversee and manage external resources providing guidance and direction for assigned projects.Provides statistical input for regulatory submissions; responds to statistical questions raised by regulatory agencies and institutional review boards.Other duties as assigned.What We Seek : Ph.D. or M.S. in statistics, biostatistics, or related field, or equivalent related work experience required.12+ years with Ph.D. or 15+ years with MS degree as a project biostatistician in the biotech / pharmaceutical industry.Strong and established track record of developing and establishing statistical excellence.Experience leading Biostatistics function supporting NDA and EMEA filings.Comprehensive knowledge of clinical trials methodology, drug development process, regulatory requirements, statistics and statistical software packages, including SAS, are a must.Experience with protocol development, clinical study reporting, ISS / ISE requirements, and regulatory submissions in paper and electronic format is essential.Ability to translate clinical study designs into statistical practice and educate study team members in the use of statistics.Ability to influence and communicate across functions.Proven strong leadership and project management skills. Demonstrated ability in managing internal and external functional / multi-functional teams and / or initiatives.Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market / competitive intelligence.Flexible to changing priorities, detail-oriented, works well under pressure with an initiative to take on unfamiliar tasks.Demonstrated ability to evaluate the business impact of decisions, follow through on agreed-upon decisions, and remain flexible when needed.Excellent analytical, problem-solving, and organization skills with the ability to work on multiple tasks.Ability to communicate technical information to non-scientists, and willingness to educate the internal team.Strong customer-orientated awareness and focus; strives to support others to succeed.Strong focus on quality with an ability to adjust to multiple demands, shifting priorities, and unexpected events while maintaining a positive work attitude.Strong team player with excellent collaboration skills.Outstanding problem-solving skills.Ability to travel as needed.What We Provide to You : The opportunity to make a difference in people’s lives impacted by autoimmune and inflammatory diseases.Participate in a team of life science professionals who value science, data, high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.Competitive compensation and a comprehensive benefit package, including stock options.Ventyx is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state and local regulations, should one be needed. The anticipated annual base salary range for this role is $230,000 to $280,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, company needs, and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, LTD, time off, a retirement plan, and other voluntary benefits for employees.#J-18808-Ljbffr