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Principal Biostatistician

2 months ago

Boston, Massachusetts, United States Galderma Full time
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare 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 are 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 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.