- Bachelor/Master's Degree/in Biostatistics, Mathematics, Statistics, Computer Science, Life Science (or equivalent degree)
- A minimum of 5 years of relevant pharmaceutical industry work experience.
- Experience writing SAS programs to create data sets, tables, figures, and listings reporting results of clinical trials.
- Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE.
- Experience with SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
- Experience with the CDISC SDTM and AdaM models and transforming raw data into these standards.
- Experience working with all types of safety data and coding dictionaries commonly used by the pharmaceutical industry.
Other Skills and Abilities:
- Excellent writing skills.
- Highly detail and quality oriented.
- A positive attitude, flexibility and a proactive thought process.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to write speeches and articles for publication that conform to prescribed style and format.
- Ability to effectively present information to top management.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical form and deal with several abstract and concrete variables.
- Strong computer skills in industry standard statistical programming.
- While performing the duties of this job, the employee is frequently required to sit, talk and hear.
- The employee is occasionally required to walk.
- The employee must utilize close vision and be able to adjust focus.
- Infrequent travel is anticipated.
- The noise level in the work environment is usually quiet.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The incumbent in this position may be required to perform other duties, as assigned.