Associate Director / Director, Statistical Programming

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).

Key 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.

Qualifications: 

• 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. Programming experience in R is a plus.
• 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.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown, MA is $193,480 to $239,300. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

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