Penfield Search Partners
Contact: Mark Maurer – mmaurer@penfieldsearch.com
Job Description: The Director position is for a skilled senior scientist with training and expertise in statistics and research who also has people-management skills with the ability to provide oversight either in a matrix set-up or as a direct supervisor. In your new role, you will be expected to lead and implement statistical strategy and foster innovation in the design and analysis of clinical trials, clinical development plans and medical evidence generation for drug-projects at company. In addition in this the role, you may have the opportunity to be a people manager with one or more direct reports. If you are a strategic thinker and a kind and empathetic problem-solver looking for an innovative, diverse and inclusive R&D organization, we are the right organization for you!
- A Director should be a strong leader on drug-development programs with the ability to drive and implement innovative statistical strategy
- Have people management skills with the ability to provide effective oversight of colleagues in a matrix set-up or as supervisor with one or more direct reports.
- Have a solid foundation in statistical methodology and statistical computing
- Partner with project teams on regulatory submissions and product defense, including interactions with regulators
- Be an analytical thinker with strong quantitative skills
- Demonstrate leadership including ability to negotiate and influence stakeholders
- Be able to make strategic statistical contributions to clinical trial design, clinical development plans, regulatory submissions, business development opportunities and medical evidence-generation in the development of new therapies or in support of life-cycle management for marketed drugs
- Develop and oversee the execution of statistical analysis plans for clinical trials and regulatory submissions
- Have strong and effective oral communication and technical-writing skills
- Contribute to the creation of a culture that is innovative, empathetic, diverse and inclusive
Qualifications:
- 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
- Ability to communicate with non-statisticians to interpret statistical findings
- Ability to program using SAS, knowledge of R
- Knowledge of relevant ICH, FDA and CHMP guidelines