- Provide statistical programming support for clinical trials.
- Utilize SAS to generate and validate CDISC SDTM, ADaM compliant datasets and TLFs based on SAP.
- Utilize SAS to generate any ADHOC related analysis for various needs (internal, publications, ect.).
- Review SDTM/ADaM TLFs for regulatory, CDISC compliance and SAP.
- Generate/Review specification for SDTM and ADAM mapping.
- Oversight of CROs to ensure quality and timely deliverables.
- Collaborate with cross functional teams on ongoing basis representing statistical programming on Study Management Teams.
- Review Statistical Analysis plan and other related docs.
- Work independently.
- Manage multiple projects/tasks, and appropriately prioritize these tasks.
The successful candidate for this position will have a proven track record of SDTM/ADAM, TLFs programming supporting clinical trial execution and regulatory submissions, and must therefore:
- Bachelor’s degree in statistics, mathematics, computer science, management information systems, or related field of study is required; MS in statistics or biostatistics is desirable.
- Have at least 7-8 years of experience in the pharmaceutical industry.
- Have strong technical SAS programming skills (at least 7-8 years) that can be used in producing various types of outputs: datasets, TLFs.
- Have strong statistical programming skills to produce deliverables either on scheduled or ADHOC basis (tables, listings, figures).
- Strong knowledge with FDA and CDISC/SDTM requirements for compliant datasets, programs, and validation processes is a must have.
- Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).
- Heavily involved in designing, developing & validating CDISC SDTM/ADAM specifications and datasets for clinical trials.
- Experience with producing outputs submitted to the FDA and other regulatory agencies (IND, ISS, ISE, Annual Reports, DSUR, post marketing support, etc.).
- Excellent knowledge of clinical trial research methodologies, CDISC, ICH, GCP and 21 CFR Part 11 rules and regulations.
- Demonstrable abilities to work on most tasks independently (with limited guidance and supervision).
- Excellent organizational skills: can prioritize multiple tasks and goals to ensure the timely completion.
- Excellent communication skills with the ability to quickly adapt to a fast-paced environment.
- Expected to communicate regularly with CRO vendors to ensure quality and on-time delivery and with members of various internal teams (data science, medical science, and program development) to provide delivery-related updates.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.