Principal Biostatistician

Galderma

Fort Worth, Texas

Date Posted December 31, 2021
Industry Private Sector BioStat Jobs
Specialty Not Specified
Job Status Not Specified
Salary Not Specified

Description:

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.

Job Description

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

  • 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.

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 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