What are the responsibilities and job description for the Senior Biostatistician position at Galderma?
At Galderma we're unique and we embrace difference.
Whether it's the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make - working here isn't like anywhere else.
At Galderma, we actively give our teams reasons to believe in our 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.
The Senior Biostatistician is responsible for leading, developing and implementing statistical solutions to the Galderma R&D sponsored clinical trials. Under the guidance of manager, provide guidance and oversight in delivering all statistical support to clinical development program.
Primary Responsibilities and Accountabilities:
* 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/Review Statistical Analysis Plan (SAP) and provide sample size calculations.
* Responsible for the Biostatistics project management including but not limited to overseeing execution of statistical analyses as per SAP, vendor management, directing statistical programming, update status of project to management on a regular basis, and escalate issues in a timely manner.
* 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.
* Author or review statistical SOPs, Guidelines and Working Instructions
* Keep up-to-date with the latest statistical methodologies development related to clinical trials.
* May serve as first point of contact for the biostatistics department within the same therapeutic indication.
* Perform Ad hoc analyses and other duties/tasks as required or assigned.
* Good knowledge of CDISC Standards, including SDTM, ADaM.
* Interact with Regulatory Agencies on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations as needed.
* Provide support for publication.
* Give statistical presentations to internal/external groups.
Qualifications:
* Master's or PhD degree in Biostatistics or related field.
* Proficiency in statistical programming in SAS required. Knowledge of R and other programming languages is preferred.
* 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.
* Must be able to work with minimum supervision.
Work Experience:
* Minimum of 6-8 years of industry experience in leading statistical activities as a Biostatistician in supporting clinical trials.
* Minimum of 6 years of SAS programming experience and knowledge of CDISC requirements.
* 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.
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. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.
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.
