Job Description

Description Senior Biostatistician - PK Analyst SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry. Job Summary Serves as lead biostatistician on clinical studies with pharmacokinetic analyses. Maintains the statistical integrity of clinical trials analyzed by SDC. Actively participates in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Primary Responsibilities Act as the lead statistician on clinical research projects with pharmacokinetic analyses Provide statistical expertise for study design of clinical trial protocols with PK analyses Write statistical and PK methods section of the study protocol, as needed Write PK statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol Program summary tables, data listings and graphical representations of clinical trials data using WinNonlin Ensure proper execution of all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data Prepare key sections of clinical study reports and various regulatory documents, including PK/PD reports or PK/PD sections of the clinical study report Perform statistical QC of final clinical study reports Provide statistical support to present PK findings and answer questions from external clients (such as FDA, Investigators) Contribute to the development of standard operating procedures for PK analysis clinical trials Represent statistical operations in PK analyses for the department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed Manage biostatistics timelines, budgets, and client expectations Adhere to all aspects of the SDC\'s quality system Comply with SDC\'s data integrity & business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Requirements Required Skills Excellent analytical skills, with the ability to process scientific and medical data specifically in WinNonlin Able to work independently Excellent knowledge of statistical programming in a WinNonlin environment Expertise in manipulating and analyzing SAS data Ability to identify data issues, present problems, and implement solutions. Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues Good leadership, organizational and time management skills, with the ability to multi-task Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) Strong interpersonal communication and presentation skills Ability to effectively collaborate across cross-functional teams Focus on quality at all times and in all situations Education Or Equivalent Experience Master\'s degree in biostatistics, statistics, pharmacology, pharamacokinetics or other related, scientific field and at least four years of relevant professional experience; or an equivalent combination of relevant education and/or experience. Why SDC We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC\'s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team!

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