Certara is the global leader in advancing modern, efficient drug development.
We provide proven modeling & simulation, regulatory and real-world value assessment software platforms and services. In partnership with our clients, we help reduce clinical trial burden, accelerate regulatory approval and increase patient access to medicines.
Our Quantitative Science Services team is the largest pharmacometric organization in the world, which enables us to assure that various career pathways are offered which match the ambition and personal interests of our employees! As one of Certara's divisions, we deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables - to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience working on thousands of drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment.
To strengthen the impact of our services on client's clinical development programs, we want to enhance and expand our biostatistics capabilities. We aim to provide our clients with a continuum of quantitative services that span different methodologies from mechanistic models through robust, yet innovative statistical evaluations of their data. All with the aim to accelerate their pipelines.
The Director Biostatistics supports and leads client early and late clinical development engagements by providing scientific and strategic biostatistics input that addresses key questions in their development programs, clinical study design considerations, model-informed drug development strategies, as well as interactions with and submissions to regulatory authorities. This individual will operate in a multidisciplinary environment, including all functional areas involved in clinical drug development, and represents the 'biostatistical conscience' on internal project teams composed of colleagues from different quantitative backgrounds.
· Work as a billable consultant (~75% of “time in the office”) on client projects. Consulting consists of a combination of hands-on evaluations, as well as project scoping, analysis plan development, results interpretation, reporting and sharing with client teams.
· Depending on size of projects and depth of experience/knowledge, the Director, Biostatistics may provide project leadership to multiple consultants, supervise project contributions of Associate Scientists and Associate Director level consultants and/or act as account leader.
· In your role as consultant, you will:
o Contribute to client clinical development strategies and study designs
o Provide statistical input into due diligence evaluations
o Interact with regulatory agencies on behalf of clients (EoPh 2, pre-NDA meetings, etc.)
o Coach statisticians/statistical programmers assigned to the project(s) (share and provide sufficient biostatistical/clinical
context/knowledge, provide clarity on tasks, etc.)
o Coordinate statistical and programming activities across various deliverables (e.g., preps for IB, ISS, ISE , EoPh 2 package)
· You may also
o Act as a trial-statistician (responsible for study design, statistical section of synopsis/protocol, statistical analysis plan, performing analyses, statistical reports, clinical study reports)
o Act as a randomization-statistician
o Participate in, or initiate departmental tasks (e.g. updating SOPs)
Education, Experience, Training, and Knowledge:
· PhD or MSc in Statistics, or Mathematical Statistics
· At least 10 years of industry/consulting experience (may be combined with academic research) working in pharmaceutical R&D, pre-clinical and clinical environments.
· Excellent working knowledge of SAS, and preferably R
· Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management, including regulatory filings.
· Experience in addressing in interacting with regulatory agencies is a requirement.
· Demonstrated skills and experience in applying biostatistics in a multidisciplinary project team setting (including leadership roles), with clients as well as internal staff.
· Good knowledge of regulatory statistical guidelines
· Deep knowledge and experience in a specific therapeutic area, such as oncology, cardiovascular, immunotherapy or pediatric products is of interest.
Skills & Abilities:
· Independent performance of statistical evaluations and development of reports
· Well-developed project planning and management skills -- work plan writing, budgeting, delivery.
· Ability to independently lead project teams and actively mentor others.
· Strong understanding of business strategy and offerings with ability to contribute project scoping and business development efforts.
· Comfortable in a client environment able to communicate with and collaborate with non-statistician scientists and key decision makers.
· Ability to identify new business development opportunities through client interactions.
· Excellent writing, editing, verbal communication in English.
· Excellent interpersonal skills.
Number of Employees Supervised: None
Percentage of Travel Required: 0% travel
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.