This role is to join our European team. We can consider flexible location options in Europe (and home based working) - including UK, Spain, Italy, France, Poland, Hungary, Romania, Serbia, Germany, Slovakia.
We invite you to learn more about our growing organisation serving our clients that are researching ground-breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day.
You will independently lead clinical study programming in accordance with the study budget and scope of work. You will use your strong interpersonal and organizational skills to set and achieve both contracted and financial objectives in the execution of the programming; you will be called upon to lead national and international trials.
Support and lead SAS programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet project needs; Provide technical expertise to the development of programming standards and procedures.
Essential functions of the job include but are not limited to:
- Review CRFs, edit check specifications and table mock-ups
- Create specifications for SDTM and ADaM datasets
- Generate blankcrf.pdf aCRFs and define.xml files
- Generate SDTM and ADaM datasets, tables, listings, and figures to support the analysis of clinical trials data
- Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Perform quality control (including documentation) for SAS programs and other study documents (e.g., presentations and reports)
- Review, maintain and approve study documents per standard procedures
- Interact with clients and lead statistical programming efforts for the project team; perform preliminary review to aid the senior level review for analysis package deliveries
- Prepare reports (i.e. patient profiles, SAP related outputs, interim analysis) for Data Monitoring Committees (DMCs)
- Assist with training of new hires; provide ongoing training and mentorship for statistical programmers
- Participate in the development and maintenance of departmental procedures/standards
- Program, test and document global utility programs and tools in accordance with standards and validation procedures
- Provide technical oversight and leadership when needed for analysis and reporting
- Considerable SAS programming experience in CRO, Biotech, Pharmaceutical company or related fields, working in Clinical Trials.
- Lead Statistical Programming experience (for Senior and Principal levels)
- Certified Advanced Programmer for SAS 9 or equivalent proficiency preferred
- Some experience with Oncology and Rare Diseases would be an advantage
- Some experience with ISS/ISE programming and submissions would be desirable
- Bachelor's degree in Statistics, Mathematics, Computer Science, or in a related field (or equivalent experience)
- Knowledge of industry standards, such as ICH guidelines, CDISC data structures, 21 CFR Part 11 and FDA guidelines
- Experience working to CDISC standards ( SDTM / ADaM dataset experience)
- Excellent organizational skills, time management, and the ability to coordinate workload to meet established deadlines
- Excellent communication and interpersonal skills to effectively interface with others (both internally and externally to foster client relationships)
- Excellent problem solving skills
- Ability to program/QC more complex analysis datasets and outputs (i.e. tables, ADaMs, efficacy related outputs, figures) in an efficient and readable manner
- Proficient in SAS macro programming
- Advanced computer skills
- Demonstrated proficiency in interpreting statistical analysis plans
- Sound judgment/decision making
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Service oriented, accountable and flexible
- Keen attention to detail in reviewing outputs for project deliverables
- Ability to fulfill a variety of data-related roles while building company strength and experience in data activities
- Follow applicable regulations, including FDA, ICH, and Precision Policies and Procedures
Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected] .
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