Associate Director/Director, Biostatistical Programming

Relay Therapeutics • Cambridge, MA

20d

About The Position

As Associate Director/Director, Statistical Programming, you will be accountable for delivery, integrity and quality of Relay’s statistical programming across the clinical studies. You will be an integrated member of the Relay Tx scientific team, responsible for the in-house statistical programming expertise for the execution of clinical studies that will translate Relay’s innovative science into impactful medicines for patients.

Requirements

• You should ideally have a master’s degree in statistics, mathematics, computer science, or related scientific/medical field.
• You have 6-10+ years of experience (considering both Associate Director and Director level) of (SAS) statistical programming experience in the pharmaceutical/biotechnology industry as a statistical programmer. Oncology experience is preferred.
• You have advanced SAS programming skills - procedures and options commonly used in clinical trial reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures desirable.
• You have a strong and hands-on knowledge of CDISC SDTM/ADaM models and transforming raw data into these standards.
• You are a motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• You are a creative problem-solver with excellent communication.
• You have strong interpersonal and organizational skills, with a high degree of attention to detail.

Nice To Haves

• Oncology experience is preferred.

Responsibilities

• Function as lead programmer to provide technical and business expertise in support of statistical programming deliverables.
• Oversee the day-to-day statistical programming activities, timelines and deliverables for in house statistical programming as well as outsourced services.
• Ensure compliance with global regulatory requirements and quality standards.
• Lead/review SDTM and ADaM specifications, Defines, Reviewer’s Guide for regulatory submissions, CDISC compliance.
• Generate/validate CDISC SDTM, ADaM compliant datasets and TLFs based on SAP.
• Create, manage and maintain the programming specifications for the integration of data across studies in support of ISS/ISE.
• Produce and/or validate tables, listings, figures and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs.
• Identify problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.

What This Job Offers

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