Manager/Senior Manager Statistical Programmer

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    "datePosted": "2026-02-05",
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    "description": "<p><span style=\"font-family: Inter, sans-serif; font-size: 10pt\"><span style=\"font-weight: bold\">Company Profile:</span></span></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">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.</span></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 10pt\"><br></span></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">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.</span></p>\n<p><br></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 10pt; font-weight: bold\">Summary:</span></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">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.  </span></p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Responsibilities:</span></p>\n<ul>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Independently develop, validate, document and troubleshoot SAS programs for the preparation of internal reports, regulatory submissions, and ad hoc analyses.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Create, validate, update, and document SAS programs to generate analysis datasets, data listings, tables, and graphs of high quality in a timely manner.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Support preparation of data packages, eCTD deliverables, and responses to regulatory agencies.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Collaborate with cross-functional departments and provide programming support as needed. Generate adhoc analysis as requested by cross-functional departments.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Contribute to the preparation of presentations for internal project teams, leadership team, and external audience.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Develop data edit checks to identify potential data issues and work with clinical data manager to issue queries.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Reviews and provides feedback on CRF designs, CRF annotations, SDTM/ADaM Specifications and SAPs.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Develop software tools, SAS macros and utilities to automate programming activities and improve programming efficiency and quality.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Provides guidance/oversight of statistical programming work being conducted by vendors, and contractors.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Oncology experience is preferred.</span></li>\n</ul>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Who You Are:</span></p>\n<ul>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Education: B.Sc. / M.Sc. in Statistics, Mathematics, Computer Science, Engineering or a related field. M.S. preferred.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">6 plus years of experience with SAS in pharmaceutical, biotechnology industry or CRO is required.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Strong expertise in CDISC including SDTM, ADaM, and Define.xml.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Experience in regulatory submissions (e.g., sNDA, NDA, IB and DSUR).</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Excellent programming knowledge of SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH and SAS/Macro language</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Good knowledge of clinical trial design concepts.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Excellent communication and interpersonal skills.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">High attention to detail, with a focus on quality and traceability in all deliverables.</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Knowledge of relevant regulatory guidelines and standards (e.g., FDA, PMDA, ICH and EMA).</span></li>\n<li><span style=\"font-family: Inter, sans-serif; font-size: 10pt\">Solid interpersonal and teamwork skills.</span></li>\n</ul>\n<p> </p>\n<p><span style=\"font-family: Inter, sans-serif; font-size: 10pt\"><em>The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.</em></span></p>",
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