Sr-Prin ClinPharm/BioPharm Biostatistician (North America Only)

Sr-Prin ClinPharm/BioPharm 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.

Job Responsibilities

Sr or Principal level Safety Biostatistician.

Must be located in North America with no sponsorship needs.

Previous experience with EP studies required.

Requested role: Project Statisticians who are experienced with clinical development, MS or PhD in Statistics/Biostatistics, 3+ years of experience, strong programming skills (R/SAS).

Primary responsibilities ( initial scope):

. 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.

4. Interrogating root cause of issues identified during ADaM /TFL/Interactive package review

Must-have qualifications:

· 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.

Other Preferences

· Spotfire knowledge.

The Safety group is looking for additional resumes. In particular, we are looking for someone with Phase III clinical development experience and strong growth potential, for example, a candidate with 2-7 years of Phase III clinical development experience.

At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a 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, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

$80,600.00 - $145,000.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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

Requested role: Project Statisticians who are experienced with clinical development, MS or PhD in Statistics/Biostatistics, 3+ years of experience, strong programming skills (R/SAS).   Primary responsibilities (initial scope): 1.  Support Safety Analytics with ADaM/TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables. 2.  Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display. 3.  Provide ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries,  including cross-checks between interactive outputs and TFLs. 4.  Interrogating root cause of issues identified during ADaM/TFL/Interactive package review Must-have qualifications: ·    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. Other Preferences ·    Spotfire knowledge. The Safety group is looking for additional resumes. In particular, we are looking for someone with Phase III clinical development experience and strong growth potential, for example, a candidate with 2-7 years of Phase III clinical development experience. If possible, we would prefer someone who recently supported Lilly phase III studies.