Provide efficient and effective programming solutions required for clinical trial analysis and reporting, including understanding major components of study protocols, creation of more complex datasets, creation of graphs using more advanced programming skills, understanding and application of more advanced statistical tests, perform basic quality-checklist code reviews, develop standardized programs to automate routine tasks; and design, write and debug macro routines.
Provide statistical representation on project and protocol teams.
Participate in the protocol development process, including responsibility for sample size calculations and the statistical section of the protocol.
Perform bioequivalence analysis and ad hoc statistical analyses, when needed.
Responsible for preparation of analysis plans, tables, figures and listings for inclusion in clinical reports.
Perform exploratory data analyses based on requirements provided by scientists or specified in analysis plans. The results from exploratory data analyses may be used for further data characterization, such as logistic regression or time-to-event analyses.
Create SAS datasets of clinical data from clinical databases, create project specific macros and formats. Proficiently create complex and difficult datasets, based upon study protocols, data analysis plans, and dataset requirements.
Participate in the evaluation and validation of SAS macros and template programs related to the creation and validation of standard submission datasets, as needed.
Develop standard macros and/or tools in SAS for data analysis and reporting.
Write, run and debug programs and macro routines.
Understand and apply the concept of data disposition to datasets created.
Validate results produced by external vendors and/or internal staff, as appropriate.
Participate in the writing, review and finalization of CSRs, abstracts, and manuscripts for publication.
Provide input and support on data and submission standards to project teams to ensure high quality and timely deliverables that meet industry standards and regulatory requirements; particularly with regard to STDM and CDASH standards, statistical programming conventions, and CTD-CRT preparation (Define.xml development, CRF annotation, FDA submission expectations and SDTM compliance rule violation resolution).
Ensure data compliance by following the established guidelines of national and international regulatory authorities.
Comply with, follow and maintain documentation of all policies and standard operating procedures as specified in the company’ s Quality Management System and Software Development Lifecycle.
Participate in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
Identify routine problems; provide recommendations based upon analysis of the situation for assigned projects.
Automate and streamline statistical analysis processes.
Understands complicated study designs from vast experience with various study designs, disease states, and dataset structures.
Recognize anomalies in data input and program output and able to communicate this information effectively.
Collaborate closely, mentor and communicate clearly with project team members of the Biostatistics, Data Management, Clinical Pharmacology and Regulatory departments on various clinical projects.
Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.
Required Education & Qualifications:
Minimum of 2 to 3 years of experience as a Clinical/Statistical SAS Programmer in the pharmaceutical, or related, industry. SAS Certification desirable.
Master of Science degree in Statistics or related field is required.
Strong SAS (Base/Graph/STAT) and SAS Macro programming skills with understanding and experience preferably in a clinical data environment.
Proficient in industry standards (CDISC), medical terminology, and clinical trial methodologies.
Strong understanding of relational database structure.
Knowledge of pharmaceutical clinical development (i.e. understanding safety deliverables, efficacy analysis) and ability to provide programming support needs for regulatory submissions.
Familiarity with the development and execution of user requirements, validation plans, operational and performance protocols.
Demonstrated teamwork, organizational, innovative problem solving and interpersonal skills required; strong verbal and written communication skills in a global environment is also necessary for success.
Able to work independently, exercise judgment in interpreting, modifying and adapting procedures, practices, methods, etc.