|Date Posted||December 31, 2021|
|Industry||Private Sector BioStat Jobs|
|Job Status||Not Specified|
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
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 to promote their personal growth all the 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 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 unparalleled, direct impact.
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.
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
Master’s degree or PhD in Biostatistics or related field, required
Ten (10) 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
The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing duties of this job, the employee may or may not be frequently/or occasionally required to:
Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
Climb stairs or ride elevators.
Lift and/or move up to 25 pounds.
Use close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
Manipulate keyboard or otherwise access computer, telephone and hand-held devices.
Be exposed to outside weather conditions while going in and out of office buildings.
Be exposed to moderate noise level usually in warehouse settings.
Be exposed to moving equipment, mechanical parts, and/or high places; or moving between air-conditioned and non-air-conditioned environments.
Travel is estimated at 10%.
Where permitted by applicable law, successful applicants m ust be fully vaccinated against COVID-19 by their date of hire to be considered for employment. Proof of vaccination required.
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 upon 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 a contract for employment, 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.
Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information, please visit our website: https://www.galderma.com/careers