Senior Principal Statistical Programmer

Description
Senior Principal Statistical Programmer

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE
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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job Responsibilities
Experience:
10+ years overall, with
strong technical expertise in ADaM and CDISC
Technical Skill Requirements (Must-Haves)
Strong ADaM expertise

• ADaM specification creation
• ADaM programming and review
• Handling complex ADaM and TFL programming tasks

In-depth CDISC knowledge

• Strong understanding and application of CDISC standards

Experience across multiple phases: Phase I, II, and III Client-facing communication skills

• Ability to interact directly with technical client leads
• Manage communication without US-based counterparts

Study Management Requirements
Proven study-leading experience:

Must have led at least 4–5 studies independently (not just co-led/supporting lead)

Experience Leading Multiple Trials Simultaneously (large/global Studies Preferred)
Ability to drive end-to-end study delivery with confidence and minimal oversight Exposure to oversight and coordination across portfolios (especially for ISS)

• Good-to-Have Skills
• Prior ISS (Integrated Summary of Safety/Efficacy) experience — preferred but not mandatory
• Exposure to handling multiple study designs
• Understanding of integration workflows

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary
This position provides statistical programming consultancy to colleagues and sponsors, leveraging project management, technical leadership abilities, and submission requirements knowledge, with a hands-on and collaborative approach, to support the conduct, statistical analysis, reporting, and submission preparation within and across projects, as well as tools and processes as required. A Senior Principal Statistical Programmer demonstrates a high degree of independence, technical skills and ability to influence the team and clients to get results with minimal to no supervision; may determine the overall strategy for the programming tasks across a program or submission; identifies trends across projects, and takes appropriate action to replicate positive results and mitigate negative ones. A Senior Principal Statistical programmer demonstrating a high degree of expertise of CDSIC and other industry standards / tools and regulatory requirements, and may serve as a subject matter expert leading innovations and providing guidance to the Biostatistics department.