Responsibilities
- Transform statistical analysis plans into high‑quality, traceable programming deliverables, including tables, listings, figures, and interactive dashboards.
- Create and validate datasets according to SDTM and ADaM standards to meet regulatory requirements and Roche standards.
- Generate data insights through platforms such as Insight Engine for real‑time exploration and interpretation of clinical and exploratory data.
- Develop, validate, and maintain datasets and statistical outputs for clinical trials, ensuring accuracy, traceability, and compliance with internal and regulatory expectations.
- Support programming outputs across various data types, including exploratory biomarker and real‑world data, for regulatory and scientific objectives.
- Collaborate on exploratory analyses across disease areas and therapeutic areas to generate insights that inform drug development strategies.
- Lead the creation and refinement of interactive analytical tools and applications (e.g., dashboards) for dynamic data exploration by scientific and clinical teams.
- Coordinate deliverables with internal and external programming partners to meet study timelines and requirements.
- Interpret statistical analysis plans and translate them into executable programming specifications to ensure scientific rigor.
- Troubleshoot and resolve technical programming challenges independently, proactively identifying risks and implementing solutions.
- Design and maintain standard macros and reusable components to promote efficiency and consistency across studies.
- Document programming workflows and maintain audit trails, ensuring study files are complete, traceable, and inspection‑ready.
- Work cross‑functionally with biostatistics, data management, and clinical operations to define programming timelines and deliverables.
- Engage in process improvement and innovation activities and participate in learning initiatives to grow knowledge of clinical research and programming standards.
Qualifications
- Hold a Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field.
- Have a minimum of 5 years of experience in statistical programming in a clinical development setting, or an advanced degree with 3 years of equivalent work experience.
- Be proficient in a modern programming language (SAS or R) and visualization/review tools.
- Have a deep understanding of statistical quality, endpoints, and QC processes.
- Possess experience with CDISC standards, specifically SDTM and ADaM.
- Have expertise in handling and analyzing multi‑modal datasets.
- Demonstrate the ability to deliver programming outputs independently.
- Respect cultural differences when interacting with colleagues in a global workplace.
- Be fluent in English.
Preferred Qualifications
- Strong attention to detail for regulatory submission processes and related documentation.
- Critical thinking, strong organizational and problem‑solving skills.
- Experience working in cross‑functional global study teams.
- Excellent communication skills with the ability to translate complex statistical concepts for non‑statistical audiences.
- Experience with multiple phases of drug development (early and/or late stage).
- Willingness to adapt, grow, and evolve in response to shifting priorities.
Benefits & Compensation
Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of Boston is $114,000 - $211,600. The actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance.
Equal Opportunity Employer
Genentech, a member of the Roche group, is an equal opportunity employer. Our policy and practice are to employ, promote, and otherwise treat all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of protected veteran status or disability status, consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing the Accommodations for Applicants form.
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