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, in addition to working across other therapeutic areas.
Precision for Medicine are looking for Senior Statistical Programmers to join our team in India! If you have experience working within a clinical research as a Statistical Programmer carrying out lead programming tasks, and are working in SAS (and to CDISC standards) we would be keen to hear from you!
We invite you to learn more about our growing organization 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 perform 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.
Support (and/or 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
Carrying out Lead statistical programming work on clinical studies
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
Mentoring more junior team members as required
Minimum 5 years SAS programming experience.
Previous SAS statistical programming experience working in Clinical Trials (in CRO, Biotech, Pharmaceutical company or related fields).
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
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
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 QuestionForHR@precisionmedicinegrp.com.