Verastem Oncology · 7 hours ago
Manager/Senior Manager Statistical Programmer
Boston, MA
Full-time
Hybrid
Senior Level
6+ years expVerastem Oncology is advancing innovation to address the needs of patients with cancers driven by RAS/MAPK pathway mutations. They are seeking a Senior Statistical Programmer to provide expert level programming support for clinical trial data, ensuring compliance with statistical analysis plans and regulatory requirements.
BiopharmaBiotechnologyPharmaceutical
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
Qualification
Required
B.Sc. / M.Sc. in Statistics, Mathematics, Computer Science, Engineering or a related field
6 plus years of experience with SAS in pharmaceutical, biotechnology industry or CRO
Strong expertise in CDISC including SDTM, ADaM, and Define.xml
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
Preferred
M.S. preferred
Oncology experience is preferred
Benefits
Annual bonus
Equity compensation
Competitive benefits package
Company
Verastem Oncology
Verastem is a biopharmaceutical company developing new medicines to improve the lives of patients with RAS/MAPK pathway-driven cancers.
51-200 employees
H1B Sponsorship
Verastem Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$626.6MKey Investors
RTW InvestmentsOberland CapitalBiotechnology Value Fund
2025-11-14Post Ipo Equity· $90M
2025-04-25Post Ipo Equity· $75M
2025-01-13Post Ipo Equity· $7.5M
Leadership Team
Dan Paterson
President and CEO
Dan Calkins
Chief Financial Officer
Recent News
Boston Globe
2026-01-03
Company data provided by crunchbase