Statistical Programmer Consultant

Roles and Responsibilities

• Lead/review SDTM specs, acrf, datasets, Defines, Reviewers Guide for regulatory, CDISC compliance, and SAP.

• 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, etc.).

• Provide 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 eCRFs, DMP, and other Data Management documents.

• Review Statistical Analysis plan and other related docs.

• Manage multiple projects/tasks independently and appropriately prioritize tasks.

Experience, Education and Specialized Knowledge and Skills

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:

• Have strong technical SAS programming skills (at least 7+ years) that can be used in producing various types of outputs: datasets, TLFs.

• Have strong technical skills to produce deliverables either on a scheduled or ADHOC basis.

• Have at least 5+ years of experience in the pharmaceutical industry.

• Bachelors degree in statistics, mathematics, computer science, management information systems, or related field of study is required; MS in statistics or biostatistics is desirable.

• Strong knowledge with FDA and CDISC/SDTM requirements for compliant datasets, programs, and validation processes is a must-have.

• Experience with Spotfire and R are a plus.

• Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).

• Heavily involved in designing, developing, and validating CDISC SDTM specifications and datasets for clinical trials.

• Experience with producing outputs submitted to the FDA and other regulatoryagencies (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.

• Expectedto communicate regularly with CRO vendors to ensure quality and on-time delivery and withmembers 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, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision and mission of Sage.