Strategic Statistical Consultant

Strategic Statistical Consultant (remote)

At Facet, our mission is to make life sciences dreams a reality. We are R&D leaders with a passion for designing and leading the implementation of innovative strategies and tactical solutions to advance great science. Our experience enables us to deliver streamlined and innovative solutions for small organizations to help expedite products to and through FDA to patients in need.

For over 10 years, Facet has leveraged our strong scientific expertise to help small organizations reach successful outcomes in the US, from product concept to commercialization. We love to tell a good story and great science makes for a great story!

If you thrive in an environment where you lead the biometrics strategy and tactical activities for small organizations developing groundbreaking products for the US market, Facet may be the perfect place to satiate your scientific curiosity, showcase your creativity, and achieve your career aspirations. Come help us create great success stories – both for our customers and for you!

Role description:

The Strategic Statistical Consultant (SSC) (Senior Director, Biometrics) is focused on helping organizations advance their drug, biologic, device, and combination product through regulated development in the US. The SSC provides expert-level strategic biostatistical and methodological guidance to commercial, academic, and other organizations to drive client value. The SSC promotes progress and innovation in the development of specific drug, biologic, device, and combination product(s) using their knowledge of traditional and novel experimental designs, various data analytic techniques, and modeling and simulations. The SSC also provides biostatistical and SAS programming support and guidance to Facet clients with respect to specific product development activities, including but not limited to trial endpoint selection, sample size estimation, data analysis and interpretation, and validation of third-party statistical output (e.g., statistical analysis plans, trial tables, listings, and graphs).

To be successful, the SSC formulates, leads, and implements successful innovative biostatistical strategies based on client input (stated goals, corporate objectives, and risk tolerance), their experience with statistical principles and ICH/FDA regulations and guidances, and strong teamwork with Facet colleagues, key opinion leaders (KOLs), and Facet and client partners. The SSC is accountable for direct interactions with FDA and relevant submission content and responses to health authority information requests. The SSC may discuss biostatistical and business strategy with client investors and/or board members and may support due diligence activities on behalf of clients under supervision.

Facet strongly supports and expects the SSC to be an active participant in service to the industry (e.g., industry memberships, conference presentations, or publications).

Success also requires strong interpersonal skills (e.g., good negotiation, conflict management), a willingness to ferret out information, manage constructive criticism proficiently, and an ability to analyze complex issues and distill them into simple yet compelling messaging.

This is a remote (work from home) full-time position. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

This role reports to the Vice President, R&D.

Key Responsibilities:

• Serve as a biostatistical and methodological expert on client projects and within Facet.
• Provide statistical programming for complex data analysis and simulations for clinical trials.
• Serve as a primary biostatistical representative with FDA for client projects, programs, and on behalf of Facet.
• Serve as a biostatistical and methodological expert with client boards, investors, and KOLs.
• Explore aggressive and innovative biostatistical designs and analytics for investigational, new, or modified products consistent with a client’s goals and stated risk profile.
• Author and/or review biostatistical documentation for regulatory submissions.
• Maintain project budgets.
• Maintain knowledge of global biostatistics landscape; traditional and innovative experimental design; ICH/FDA biostatistical regulations and guidances.
• Actively contribute to the development and maintenance of Facet and departmental knowledge, working practices, and procedures.
• Maintain leadership service within the industry (e.g., industry memberships, conference presentations, publications).
• Assist with the preparation of sales materials and client draft contracts.
• Any other duties assigned by management

Experience and Skills Desired:

• Advanced degree in mathematics or statistics, or related discipline (e.g., MS, Ph.D.) strongly preferred
• At least 5 years of recent SAS programming experience in regulated pharmaceutical, biopharmaceutical, or medical device industry
• Ability to analyze complex information (i.e., trial designs, statistical methods, trial results, medical information)
• Proficient in evaluating and accurately portraying conflicting information
• Ability to distill complex information into clear, compelling, data-supported messaging
• Strong organizational skills and attention to detail
• Strong time management skills
• Expert in MS Word, Excel, and Power Point
• 21 CFR Part 11 document management experience desirable

Benefits and Compensation:

We are a small company with big company benefits. Providing great benefits to keep our Facet colleagues healthy and happy is a core value for us. We provide our team members with top-notch benefits:

• Health insurance plan
• Supplemental insurance
• Dental insurance
• Life insurance
• Short- and long-term disability insurance
• 401K program
• Several bonus programs
• Company-supported, required annual training
• Flexible work environment
• Unlimited sick and vacation