Researcher / analyst
Company InfoTeva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth! Job Description
The Principal Statistician position is for a skilled scientist with training and expertise in statistics and research. He or she is expected to provide statistical support to clinical studies within Teva Global R&D.
The support includes, but not limited to, study design and data analyses. This role will require knowledge about statistical principles and appropriate software and tools to perform tasks. A Principal Statistician should be a strong individual contributor with the ability to influence and should further demonstrate leadership qualities and strategic thinking.
They will consult for clinical endpoint assessment and sample size planning. Conduct simulations to support study design and analysis and influence decision making. In addition they will prepare or oversee the preparation of statistical section of the clinical protocols in collaboration with key stakeholders when deemed necessary.
- Writes, or oversees the writing of, statistical analysis plans and validation plans
- Conducts analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses and regulatory responses.
- Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies as appropriate
- Proactively assesses and identified processes that require improvement
- Participates in department initiatives to further the effectiveness of Global Statistics
- Learns and implements innovative and cutting-edge clinical trial design, methodology and analysis
- PhD in Statistics, Biostatistics or related field of study
- Master’s degree in Statistics, Biostatistics or related field of study with minimum of 4 years of experience in clinical statistics
- Technical leadership abilities
- Knowledge of relevant ICH, FDA and CHMP guidelines
- Good organizational and problem solving skills
- Project and technical leadership qualities
- Able to think strategically