Job Overview:As a Director, Biostatistics, you will serve as a thought leader in statistical methodology for clinical trial design. You will serve as a part of a larger team in a statistical consultancy role, providing high level guidance to both internal and external clients. Each member of the team is expected to specialize in at least one area of statistical leadership and will serve as subject matter expert. You will lead that associated body of work as well as fulfil general consulting roles as needed. You may also be a member of data monitoring committees, either as blinded or unblinded statistician.
Our remit is trial and program design, along with associated analyses. Team members will help write protocol synopses for clients as part of a team which includes medical, pharmacokinetic, and operational experts. Occasionally we may contribute to full protocols and provide consulting in advanced statistical analyses. Trial designs of particular interest include biosimilars, adaptive designs, master protocols, Bayesian analyses, and related statistical methods.
Thought leadership is expected from team members, which includes publishing papers in peer-reviewed journals, referee, and editor work, presenting talks at scientific conferences, and participating in our by-invitation-only webinars. Management of people and projects is also possible depending on interest. Participation in bid defences is expected, as is some travel to clients.
Management responsibilities can be tailored to the interest of the candidate. This position can be either home- or office-based. Position level depends on experience.
Requirements:- PhD or MSc degree in Statistics, Biostatistics, or related field, along with 11 to 13+ years' experience within the life-science industry, PhD preferred.
- Strong knowledge of complex statistical methods that apply to applicable clinical trials
- Must have experience with clinical trial design, adaptive design strongly preferred
- Must have some knowledge of regulatory bodies and compliance within the pharmaceutical and CRO space. FDA experience is preferred.
- Strong working knowledge of SAS and CDISC SDTM and ADaM
- Ability to effectively manage multiple tasks and project, ability to communicate and explain statistics
- Experience preparing budgets/proposals and participating in bid defences and
- Experience publishing papers or presenting talks at scientific conferences and/or in webinars
What is in it for you?- Interesting and innovative projects
- Collaborative and inspirational working environment / atmosphere
- Excellent career development and progression opportunities
- Work - life balance
The potential base pay range for this role, when annualized, is $134,800.00 - $375,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
