Senior Statistical Programmer ~ SAS

Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history

Please join us in driving the development of new therapies that seek to transform patients' lives. If autonomy and collaboration in tackling challenges is what you are seeking and you would like to be part of a hardworking team where everyone has a voice, please join in our mission!

Reporting to the Director of Statistical Programming, the Senior Statistical Programmer is responsible for developing study-level deliverables throughout the drug development life cycle. This role requires extensive knowledge of CDISC standards, clinical trial databases, and statistical programming best practices. The Senior Statistical Programmer will create and validate CDISC-compliant SDTM & ADaM datasets, TLFs, and various reports to support clinical data review. Additionally, the role involves preparing documentation for programming activities and electronic submissions. Collaboration with the Director and the statistical programming team is essential.

Key Responsibilities:

• Develop, test, and validate SAS programs in accordance with applicable SOPs and industry standards for the creation of tables, listings, figures, and CDISC compliant SDTM and ADaM datasets.
• Read, understand, and follow applicable technical specifications documents when developing SAS programs.
• Work collaboratively to meet deadlines for statistical programming deliverables within overall project or study schedules.
• Ensure adherence to internal standards and procedures for all statistical programming activities.
• Participate actively in internal programming team meetings.
• Contributes to the development of process improvements for programming activities.
• Stay current with regulatory requirements for CDISC and clinical regulatory programming standards including therapeutic area-specific standards.

Requirements:

• A B.S.(or higher) in Statistics, Computer Science or other field closely related to programming with a minimum 6+ years of relevant pharmaceutical/biotech industry statistical programming experience.
• Solid knowledge of CDISC standards, statistical programming principles, clinical trials processes and regulatory requirements.
• Prior neuroscience & oncology/hematology experience highly desirable.
• Dynamic self-starter; agile learner; strategic and creative problem solver.
• Demonstrated, strong problem solving and risk-mitigation skills.
• Excellent verbal, written and interpersonal skills required for working successfully in a team environment.
• Strong, well-rounded technical skills (SAS, Python or R, EDC systems, MS Word, Excel) and knowledge of industry standards (CDISC, SDTM, ADaM, etc.).
• Demonstrated ability to create complex SAS programs free from dependence on external macros or a supportive code infrastructure.
• Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS/GRAPH.
• Detailed knowledge of SAS statistical procedures including GLM, LIFETEST, LOGISTIC, MI, MIANALYZE, MIXED, NPAR1WAY, and PHREG.