Description
Roles and Responsibilities
Lead/review SDTM specs, acrf, datasets, Defines, Reviewer's 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.
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.
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 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, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
Excitement about the vision and mission of Sage.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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Pay Transparency Nondiscrimination
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.
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