Director, Biostatistics

Overview:
**About Certara**

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 phase clinical development engagements by providing scientific and strategic biostatistics input that addresses key questions in their development programs, clinical study design considerations, 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.

**Responsibilities**:

- Work as a billable consultant 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 Scientists and Associate Scientists level consultants and/or act as account leader.

In your role as consultant, you will:

- Play a leadership role in the design of clinical trials, providing input on study design, trial size, endpoints, etc.
- Author biostatistical sections of protocols and statistical analysis plans for clinical studies across indications
- Provide statistical input into due diligence evaluations
- Author statistical section of regulatory submissions; provide input on submissions and regulatory strategy from a biostatistics perspective
- Interact with regulatory agencies on behalf of clients (EoPh 2, pre-NDA meetings, etc.)
- Coach statisticians/statistical programmers assigned to the project(s) (share and provide sufficient biostatistical/clinical context/knowledge, provide clarity on tasks, etc.)
- Coordinate statistical and programming activities across various deliverables (e.g., preps for IB, ISS, ISE, EoPh 2 package)

You may also:

- Act as a trial-statistician (responsible for study design, statistical section of synopsis/protocol, statistical analysis plan and TLF shells, performing analyses, authoring statistical reports, authoring relevant sections of clinical study reports)
- Act as a randomization-statistician
- Participate in, or initiate departmental tasks (e.g., updating SOPs)

Qualifications:

- PhD or MSc in Biostatistics, Statistics, or Mathematical Statistics
- 10 years for PhD (15 years for MSc) of clinical development experience, with an emphasis on statistics, design, and analysis of early and late-phase clinical studies
- 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
- 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 interacting with regulatory agencies is a requirement
- Good knowledge of US and ROW regulatory 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 off