Manager/Senior Manager Statistical Programmer Programmer - Boston - Verastem

    Verastem
    Verastem Boston

    1 week ago

    Description

    Company Profile:
    At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan.
    We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.
    Summary:
    We are looking for a Sr. Statistical Programmer who will provide expert level hands-on programming support to develop, maintain, validate programs in SAS that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. Activities will include, but are not limited to review of Statistical Analysis Plans(SAP), Annotated Case Report Forms(aCRF), Development/Validation of ADaM/SDTM Specifications and datasets, and Tables/Listing/Figures(TLFs), , and support ad-hoc statistical analyses. The ability to work independently with a strong expertise in SAS/GRAPH programming experience is required.
    Responsibilities:

    • Independently develop, validate, document and troubleshoot SAS programs for the preparation of internal reports, regulatory submissions, and ad hoc analyses.
    • Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance.
    • Create, validate, update, and document SAS programs to generate analysis datasets, data listings, tables, and graphs of high quality in a timely manner.
    • Support preparation of data packages, eCTD deliverables, and responses to regulatory agencies.
    • Collaborate with cross-functional departments and provide programming support as needed. Generate adhoc analysis as requested by cross-functional departments.
    • Contribute to the preparation of presentations for internal project teams, leadership team, and external audience.
    • Develop data edit checks to identify potential data issues and work with clinical data manager to issue queries.
    • Reviews and provides feedback on CRF designs, CRF annotations, SDTM/ADaM Specifications and SAPs.
    • Develop software tools, SAS macros and utilities to automate programming activities and improve programming efficiency and quality.
    • Provides guidance/oversight of statistical programming work being conducted by vendors, and contractors.
    • Oncology experience is preferred.
    Who You Are:
    • Education: B.Sc. / M.Sc. in Statistics, Mathematics, Computer Science, Engineering or a related field. M.S. preferred.
    • 6 plus years of experience with SAS in pharmaceutical, biotechnology industry or CRO is required.
    • Strong expertise in CDISC including SDTM, ADaM, and
    • Experience in regulatory submissions (e.g., sNDA, NDA, IB and DSUR).
    • Excellent programming knowledge of SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH and SAS/Macro language
    • Good knowledge of clinical trial design concepts.
    • Excellent communication and interpersonal skills.
    • High attention to detail, with a focus on quality and traceability in all deliverables.
    • Knowledge of relevant regulatory guidelines and standards (e.g., FDA, PMDA, ICH and EMA).
    • Solid interpersonal and teamwork skills.
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