Website Pharmaron
Department： Statistical Programming
Responsibilities：
- Perform SAS data processes and analysis programming.
- Works with Statistician and Statistical programmer to assure results are consistent with expectations, and Quality control procedures are
followed.
- Lead the development and delivery of training.
- Act as primary contact to ensure that company standards are
implemented in all studies.
- Works collaboratively to meet study deliverables and timelines for
statistical data analysis and reporting.
- Plans and carefully documents differences between programming
results between program developer and Statistical QC programmer.
- Provided programming support on ISS/ISE and post-submission
activities.
- Provide flexible and rapid responses to programming requests.
- Ensure consistency and adherence to standards within the project.
- Confirms that tracking sheets are current for projects, and confirm
that results are consistent with earlier generated results.
- Maintain up-to-date study documentation.
- Identify opportunities to improve the methodology and provide
practical solutions for problems.
- Develop, program, test, and maintain computer validation/edit checks
in SAS.
- Validate peer programming.
- Provide technical expertise and support to the Data Management
team.
- Routinely interface with cross-functional team members.
- Participate in regular team meetings and provide input when
appropriate.
- Participate in the development of clinical programming SOPs and the
development/optimization of clinical programming processes from
study start-up to database lock.
- Managing project priorities and timelines.
- Have good knowledge of statistical terminology, clinical data
structure, clinical tests, medical terminology, regulatory standards, and protocol designs.
- Review programming activities and costs in contracts.
- Direct responsibility for supervising and training junior clinical
programmers in the performance of their duties.
Qualification：
- BS degree or higher in programming or statistics.
- SAS Experience in Pharmaceutical or equivalent: >=5 years
Oncology experience preferred.
- Understanding of GCP, ICH, and FDA guidelines and regulations
applicable to conduct clinical research.
- Knowledge of CDISC standards and industry best practices.
- Have good knowledge of statistical terminology, clinical data
structure, clinical tests, medical terminology, regulatory standards
and protocol designs.
- Strong SAS programming / Macros development / SAS graphs skills.
- Excellent oral and written skills for cross-site and cross-function
collaboration.
- Dependable, motivated, focused, and detail orientated.
- Ability to take direction as needed and work independently on projects
when necessary.
- Capable of managing time effectively and adhering to timelines and
project schedules Complementary Skills.
- Working knowledge of SAS modules and utilities.
- Ability to develop routines using the SAS Macro Language.
- Strong SAS programming / Macros development / SAS graphs skills.
- Understanding of biotech industry regulatory requirements.
- Ability to use Microsoft Office tools: Word, Excel, PPT, etc.
Contact：
Please submit your resume and CV to mia.terwilliger@pharmaron.com and mention that you saw this JD on the SAPA website.