Title: Principal Biostatistician

Location: Boston, MA or remote

The Principal Biostatistician is responsible for leading, developing and implementing statistical solutions to the Galderma R&D sponsored clinical trials. Under the guidance of Head of Biometrics, this role provides leadership in delivering all statistical support to clinical development program.

Responsibilities:

• Serve as biostatistics leader for a particular therapeutic indication of a project

• Participate and interact with clinical and cross-functional teams in the development of protocols, study design and endpoints discussions

• Develop and review Statistical Analysis Plan (SAP) and provide sample size calculations

• Lead Biostatistics project management work, including but not limited to: overseeing execution of statistical analyses as per SAP, vendor management, directing statistical programming, mentoring junior statisticians, updating status of project to management on a regular basis, and escalating issues in a timely manner.

• Support NDA/BLA/MAA submission work and generation of ISS/ISE

• Ensure high quality and timely delivery of tables/figures/listings and statistical reports

• Prepare or review statistical sections of clinical study report and overall summaries

• Execute quality assurance procedures on work produced by others, ensuring statistical analysis is being done according to specifications

• Interact with Regulatory Agencies on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations

• Provide support for publication

• Author or review statistical SOPs, guidelines and working instructions

• Keep apprised of the latest statistical methodologies development related to clinical trials

• Give statistical presentations to internal/external groups

• Perform other duties/tasks as required or assigned

Requirements:

• Master's degree or PhD in Biostatistics or related field, required

• Eight (8) or more years of industry experience in leading statistical activities as a Biostatistician in supporting clinical trials, required

• Six (6) or more years of SAS programming experience and knowledge of CDISC requirements, required

• Experience working on NDA/BLA/MAA submission work and have worked in the planning and generation of ISS/ISE

• Proficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferred

• Extensive knowledge of statistical methodologies and study designs.

• Experience with regulatory support and interaction, preferred

• Experience in providing vendor oversight

• Proven ability to manage multiple projects across therapeutic indications

• Excellent verbal and written communication skills

• Ability to work as a team and have skills to convince your position in cross-functional teams

• Proven ability to present and communicate statistical concepts and ideas clearly

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

Next Steps

• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.