Performs statistical analysis on data related to product development in a research and development environment. Uses statistical software (SAS, R, etc) to create and maintain listings, tabulations, graphical summaries, and formal statistical estimates and tests. Creates datasets in a standard format (i.e. SDTM), analysis datasets (i.e. ADaM), assesses quality of data analysis programs, and develops automated analysis tools, where appropriate. Develops programs to assist with data review such as edit checks and custom listings. May be responsible for data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies. May partner with biostatisticians and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Independently develops SAS or other programs, and specifications (e.g. SDTM, ADaM), for use in study or other analyses, such Integrated Safety Summaries.
* Must be able to program defensively, check results, and consistently produce accurate output.
* Independently verifies other programmer's results.
* Serves as oversight, point-of-contact, and quality control for datasets in SDTM and ADaM format as well as tables, listings, and figures (TLFs) produced by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.
* Adheres to FDA regulations and company policies regarding training records, guidelines, and SOPs.
* Supports ad-hoc requests as needed.
* Works on multiple tasks at the same time and prioritize tasks to meet business needs.
* Trouble-shoots technical and project issues.
* Helps with the infrastructure development of the department.
* Assists team to ensure timelines for the study and/or project are met.
* Assists with training new employees and contractors, in particular on study specifics and departmental programming conventions and standards.
* Communicates with outside departments and/or CROs.
* Meets timelines on a regular basis.
* BS/BA degree in related discipline and five years of related experience; or,
* MS/MA degree in related discipline and three years of related experience; or,
* PhD in related discipline and one year of related experience, or;
* Equivalent combination of education and experience.
* May require certification in assigned area.
* At least 5 years experience in statistical programming with clinical data and SAS.
* Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS Macros.
* UNIX, S-Plus, CDISC, and SAS/GRAPH experience desirable.
* Ability to communicate verbally and in writing in a clear and timely manner.
* Experience in Biotech/Pharmaceutical industry preferred.
* Has extensive experience in relevant industry/profession and area of specialization.
* Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
* Identifies and implements methods and procedures to achieve results.
* Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
* Performs a variety of complicated tasks with a wide degree of creativity and latitude.
* Has complete understanding and wide application of technical principles, theories, concepts and techniques.
* Has good general knowledge of other related disciplines.
* Applies strong analytical and business communication skills.
* Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
* Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
* Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
* Networks with key contacts outside own area of expertise.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.