Job Description - Sr Pharmacokineticist (21005358)
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
#SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
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.
Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or non-clinical) data using tested or validated software
Write the pharmacokinetic and statistical sections of clinical (Phase I to 3) reports including interpretation of the results
Participate in intra- and/or extra-company scientific consultancy
Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during the course of clinical studies
Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid
Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in in-house database.
Write/review standard operating procedures related to his/her work
Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians
Participate in the development of structured and standardized data modeling practices and related SOPs
Act as a consultant in clinical pharmacology study design development (e.g. optimal sampling, protocol review, etc.)
Write data analysis plans in collaboration with the statisticians and pharmacometricians
Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.
What we’re looking for
Master’s degree in Science
Relative alternate certification may be considered acceptable.
This determination ensures the jobholder has sufficient technical ability to perform the role.
5 years of relevant work experience would be considered an asset.
Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel and mathematical/statistical programming (e.g. SAS, S-Plus/R, NONMEM, WinNonlin, Pearl).
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Experience in regulatory context will be considered an asset
Demonstrate scientific problem solving skills
English level: Required bilingualism includes communicating verbally and in writing on topics that are often technical, and writing procedures or technical reports.
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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