Principal Biostatistician

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Title: Principal Biostatistician

Location: Boston, MA (2-3 days a week in office)

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