Clinical statistical programmer job 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

As our new Statistical Programmer, you will be responsible for leading, developing and implementing statistical solutions to the Galderma R&D sponsored clinical trials. Within this role, you will perform statistical programming activities for all assigned clinical studies sponsored by Galderma.

Job Responsibilities

Provide statistical programming expertise with respect to Statistical Programming, Biostatistics Perform/Coordinate all statistical programming related tasks Support the development of tables, listings and figures for assigned projects Work closely with statisticians to deliver all the statistical deliverables Create derived data set specifications for all assigned studies and integrated summaries Provide oversight and guidance to CRO for all statistical programming related activities, including development and validation of ADaM Review statistical analysis plans for all assigned studies and integrated summaries and provide comments to study biostatistician Review annotated case report forms and provide comments Contribute to process improvement initiatives as assigned


Minimum Requirements


Minimum of 6-7 years of SAS Programming experience including statistical programming experience in pharmaceutical setting Extensive experience in applying SAS programming language, preferably in pharmaceuticals setting Very good knowledge of CDISC Standards, including SDTM, ADaM Master's or bachelor's degree in Statistics, Mathematics, Computer Science, or any related field Knowledge in SAS macros Good understanding in statistical methods used in statistical analysis Ability to review protocol and SAP and provide feedback Good understanding in Good Programming Practices in pharmaceutical industry Fundamental knowledge of GCP standards Good interpersonal skills

A statistical programmer provides timely support to the study team on all programming matters according to the project strategies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. The incumbent implements and executes the programming and project standards. Works independently in the design and testing of program logic, coding programs, program documentation and preparation of programs. Supports ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical ad hoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment.
Responsibilities:

Support programmer within a study team involved in the creation and QC of analysis datasets TFL's or standard tools following standard data models or user requirements. Apply standard tools developed for the study or project. Participate in development of new standards and tools. Follow all company SOP and guidelines in the creation of the programming deliverables. Adheres to procedures surrounding retention of data, records, and information for clinical studies.


Requirements:

SAS, (Base, Stat, Macro, graph).

MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 5 -7 years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. SAS Certification a plus.

Experience in SAS programming, preferably in a clinical data environment.

Exposure of relational database structure

Understanding of reporting systems.

Experience with implementing standardization methodology.

Demonstrated teamwork and interpersonal skills, strong verbal and written communication skills in a global environment.

Ability to support study requirements with challenging timelines under direct supervision by the programming lead

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Are you ready to discover your extraordinary potential at Labcorp Drug Development? A career here provides the unique chance to create a lasting impact and difference in patients' lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy, innovative & collaborative workplace, along with access to comprehensive benefits. Your work is meaningful, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training, and personalized development planning. Our mission is to help our clients bring the miracles of medicine to market soonerjoin us for your next career move.
What we offer?



In addition to work in a global company with several career opportunities we offer private life/health/dental insurance for you and your family and many other benefits.This is a great stepping stone for a career in clinical trial programming!



What you will bring to the table?


Good organizational skills and the ability to prioritize own work. Self-motivation. Good time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work. Effective communication skills. A cooperative and team oriented approach.


Job description:



A full time position that starts with a 3-month training period provided by the company then leads to project team work in the department:


Develop and maintain SAS programs to create SDTM and ADaM datasets and create Table, Figures and Listings to support clinical trials.
Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADaMs.


Minimum Required:


Master's in programming, statistics, math, computer science, engineering, computing, public health or related. Job or college experience or exposure to data analytics programming languages (R, python, SAS, SQL, Julia).Good organizational skills and the ability to prioritize own work. Fluent English (required)


Preferred skills:


Related job or experience Data manipulation skills such as Extract/transform/load (ETL) processes and automation. Statistical analysis acumen (Exploratory data Analysis).


Labcorp is proud to be an Equal Opportunity Employer:


As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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