This role is responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data sets for one or more compounds/indications or therapeutic areas. This role must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical Operations.
location: Telecommute
job type: Contract
salary: $60.00 - 75.16 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- In depth knowledge on CDISC Standards, SAS programming concepts and techniques appropriate to the pharmaceutical industry.
- Experience in leading compound level data integration efforts to create pooled ADAM datasets by pooling data from multiple studies, completed and ongoing, across indications.
- Experience in ADaM specs and SAS programs development supporting ISS/ISE ADaM programming and submissions.
- Oversee and responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and ISE following Company's SOPs, department, and project standards.
- Experience in supporting IB, DSUR and Annual Safety Reporting deliverables.
- Ability to quickly learn internal macros, processes and programming environment.
- Team player with excellent communication skills and experience working with stat programmers, statisticians, data management personnel and Pharmacovigilance stakeholders.
- Oversee and responsible for the creation and accuracy of derivations as defined in the protocol and statistical analysis plan.
- Ensure internal consistency of output and assess consistency with other activities for the project (Pooled data vs. ISS, Study data), as applicable.
- Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
- Ensure all Company's process improvements are implemented.
- Provide accurate and timely responses to requests from clients with a sense of urgency.
- Be compliant with training requirements.
qualifications:
Required:
- At least 8 years of SAS programming experience in the pharmaceutical industry.
- Extensive experience with clinical trials and regulatory agency expectations (FDA and EMEA).
- Strong hands-on experience in creating and validating SDTM and ADaM datasets.
- Proficiency in SAS programming, including macro and utility development.
- Excellent communication skills, both written and oral.
- A Bachelor's or Master's degree in Statistics, Computer Science, or a related field.
- Experience leading compound-level data integration efforts.
- Familiarity with CDISC data standards.
skills: SAS, ADaM, CDISC, SDTM, Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), Food and Drug Administration (FDA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
