Associate Director / Director, Statistical Programming

Treeline Biosciences • Watertown, MA

14d • $193,480 - $239,300

About The Position

Associate Director / Director, Statistical Programming The Statistical Programmer will be an internal subject matter expert and lead statistical programming activities, including hands-on programming, development of standards and SOPs, and management of CROs to ensure generation of accurate and reproducible results which comply with regulatory standards, ICH guidelines, and CDISC standards (SDTM, ADaM).

Requirements

• BA/BS degree in Statistics, Applied Mathematics, Computer Science, Life Sciences, Engineering or related field.
• At least 7 years of experience working as a Statistical Programmer in pharma or biotech developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Experience and understanding of the Oncology therapeutic area.
• Exceptionally strong statistical programming in SAS which includes experience creating macros and implementing advance statistical techniques.
• Knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies including electronic submission standards.
• Strong organizational, time management, communication and project coordination skills.
• Must be able to effectively manage workload, collaborate with key stakeholders, and prioritize tasks in a dynamic environment.
• Ability to comprehend analysis plans including an understanding of statistical terminology and concepts.
• Ability to resolve issues with minimal supervision and understands when to escalate.

Nice To Haves

• Programming experience in R is a plus.

Responsibilities

• Provides hands-on programming support to generate analysis datasets and statistical outputs ensuring the generation of accurate and reproducible results.
• Independently develops, validates, and maintains complex programs including standard SAS macros for efficient analyses of clinical data in accordance with predefined specifications.
• Under the direction of the Head of Biometrics, develop and execute standard data and programming strategies across trials and programs including the creation, validation, and maintenance of programming standards, templates, macros, and standard operating procedures (SOPs).
• Contributes to development of eCRFs, edit checks, statistical analysis plans (including mock table, listing, and figure shells), programming specifications (eg. SDTM, ADaM specs), regulatory reviewers guide documents, ensuring alignment with project objectives, clarity and completeness of programming requirements, and robustness of assumptions.
• Participates in the selection and oversight of CROs and FSPs for statistical programming services including directing, reviewing and approving deliverables, including SDTM and ADaM datasets, specifications, and analysis outputs (tables, listings, and figures) ensuring programming consistency across protocols and projects.
• Contributes to the development and maintenance of timelines for programming deliverables including input into resource forecasting to achieve deliverables.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees