Sr-Prin Safety Biostatistician (North America Only)

Syneos Health

8d

About The Position

Sr-Prin Safety Biostatistician (North America Only) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Requirements

• Must be located in North America with no sponsorship needs.
• Project Statisticians who are experienced with clinical development
• MS or PhD in Statistics/Biostatistics
• 3+ years of experience
• strong programming skills (R/SAS).
• Strong experience reviewing ADaM datasets and TFLs (standard and customized output review).
• Ability to follow data specifications and programming specifications and provide clear, actionable review comments.
• Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors.
• Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward.
• R/SAS programming skills.

Nice To Haves

• Spotfire knowledge.

Responsibilities

• Support Safety Analytics with ADaM/TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables.
• Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display.
• Provide ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs.
• Interrogating root cause of issues identified during ADaM/TFL/Interactive package review

Benefits

• company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• flexible paid time off (PTO) and sick time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees