Inotiv is a drug discovery and development company with more than 500 employees at 6 sites that provides contract research services to emerging biopharmaceutical companies and the world’s leading drug development companies, as well as medical device organizations. By coupling world-class scientists and experience with state-of-the-art technology Inotiv is able to deliver contemporary study designs and program execution for biopharmaceutical companies across many therapeutic areas.
Inotiv’s accelerating growth is fueled in part by a drive to contemporize and innovate across the organization. As Inotiv leverages internal collaboration and diversification to offer best-in-class service to customers, we are committed to expanding into the Pharmacometrics / Biostatistics solutions arena for clients covering the discovery through development continuum without a compromise to quality.
As demand for Pharmacometrics / Biostatistics analysis increases, the need for a dynamic team with diverse experience will become increasingly important as we evolve and to adapt to scale in a rapidly growing environment. As such, the Inotiv DMPK department is seeking a Biostatistician to play a key role in this evolution.
The Biostatistician should have excellent knowledge and experience using industry standard software, with an interest in continued expansion of department capabilities in the Pharmacometrics / Biostatistics arena. As this position presents an opportunity to interface with clients, an understanding of the drug discovery process as well as early-stage pharmaceutical development is also desired.
The Biostatistician will work closely with DMPK leadership and scientific group leaders as consummate bridge-builders interface between DMPK scientists and project teams (inter-site and inter-departmental), to effectively managing expectations and client satisfaction.
The Biostatistician will thrive in a collaborative and welcoming environment that values a culture of empowerment, transparency, innovation, agility, professional growth, and credibility.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Provide statistical support at the study or project level in compliance with regulatory guidelines, including experimental design and statistical analysis for routine clinical and non-clinical studies
- Analyze study data using the statistical methodologies according to the study protocol and regulatory requirements
- Review analysis results with project team and generate high quality Statistical Reports for clients
- Provide support for regulatory questions regarding Biostatistics
- Support evaluation of alternative experimental designs, analysis methods, and statistical theory as relevant to client projects
- Keep abreast of relevant literature and new developments in statistical methodology
- Work with team members to develop and refine group processes
- Develop successful working relationships with individual scientists, project teams, Data Management, Quality Assurance, Regulatory Affairs and Project Management
- BS in Statistics/Biostatistics and seven years qualified experience supporting pharmaceutical product R&D, and/or pre-clinical/clinical studies or
- MS in Statistics/Biostatistics and five years qualified experience supporting pharmaceutical product R&D, and/or pre-clinical/clinical studies or
- PhD in Statistics/Biostatistics and three years of qualified experience supporting pharmaceutical product R&D, and/or pre-clinical/clinical studies.
Skills, Specialized Knowledge and Abilities:
- Required software proficiency: SAS, R, MS Office applications
- Preferred ability to perform SAS and R programming to support the analysis of data using linear mixed models, generalized linear mixed models, survival and categorical methods
- Consistently applies a solid foundation of statistical scientific/technical knowledge
- Conduct power calculations, assess experimental designs, conduct analyses, and provide interpretation of results
- Communicate statistical information to non-statisticians
- Work independently and with other Biostatisticians to determine appropriate statistical analysis methods and efficient experimental designs to address project objectives
- Interact with regulatory authorities on statistical issues at the project level
- Manage project(s) from a statistical perspective
- Work within team environment in determining the most effective and efficient designs to address project objective
- Self-driven, creative, and entrepreneurial by being resourceful, optimistic, fiscally responsible, innovative, fearless, determined, open-minded, and focused.
- Balanced and dynamic communication style that radiates honesty, integrity, and credibility through effective use of active listening skills and follow through.
- Superior relationship-building skills with all levels of internal and external stakeholders and clients.
- Compelled to join highly desirable and sought-after employer that will drive their development toward their aspirations.
- Naturally inquisitive and adept at crafting lines of questions that reveal deep and complete insights into situations and challenges.
- Self-assured and confident, yet humble and open-minded; place the team ahead of personal interests and ambitions.
- Solutions-oriented personality that embraces challenges as opportunities and demonstrates a persistent drive to take initiative and diplomatically resolve issues or challenges
- Strong sense of personal accountability and responsibility; propels throughout the organization.
- Assertive and driven to exceed expectations in a way that inspires others to do the same.
- Exceptional attention to detail and quality; strong organizational capabilities.
At Inotiv our team members come together in support of an organization focused on delivering the experience, knowledge, and responsiveness demanded from an industry striving to bring new cures to market more safely and faster than ever before. Come join our team!
Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K participation with company match, etc.
Inotiv is an equal opportunity employer and an E-Verify employer.