We are currently searching for skilled professionals to join our client's team as an Associate Director/Director, Statistical Programming in Princeton, NJ.
Provide project leadership and programming support for clinical studies including Statistical Analysis Plans and programming specifications by providing mentorship in implementing and executing the programming and project standards.
Evaluate and development study requirements, validation plans, design and test program logic to support ongoing clinical studies requests for statistical and non-statistical analyses.
Support and/or lead programmer for programming and QC of analysis datasets, TFL's or standard tools following standard data models or user requirements.
Create and be able to perform quality control of ADaMs to ensure submission requirements are met
Performing quality control of ISE/ISS datasets, tables, figures and listings with quality within the timeline.
Integration of data across studies in support of CSS/CSE. Build, manage and maintain the programming specifications for the analysis datasets.
Support creation and validation of e-submission requirements (i.e. annotated CRF, data export files, define documents).
Required Education, Experience and Certifications:
Minimum educational experience is a BS in computer science, mathematics, statistics or related analytic field.
Preferred educational experience is a Master's degree in Statistics/Biostatistics in the biopharmaceutical industry, with knowledge of biomedical sciences
Minimum of 10 years of SAS programming and application development experience in pharmaceutical/biotech company
Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
Thorough knowledge of functional areas within the clinical development organization including but not limited to clinical operations, data management, statistics, medical writing and regulatory affairs. Deep understanding of the statistics/data management role in the broader clinical development setting Solid, hands-on knowledge of the use of statistical software (e.g., SAS or SAS Jump including SAS/GRAPH, and SAS/STAT), including report generation is necessary. Prior work experience in the CDISC SDTMs and ADaMs is a must; Experience with ADaM specs writing/review highly desirable Knowledge of coded terms for the adverse events and concomitant medication datasets from MedDRA and WHODrug dictionaries
Experience with creating patient profile/narratives highly valuable
Prior experience in electronic NDA/BLA submissions via eCTD and responding to FDA/regulatory requests.
Excellent verbal and written communication and interpersonal skills. Demonstrated ability to work in a team environment. High degree of motivation; results oriented.
Strong familiarity with a variety of clinical data and databases (including EDC system
Working knowledge of SDTM / ADaM standards (in the absence of ADaM experience, considerable experience working with analysis or derived datasets).
Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time.
Proficiency with MS Office applications (e.g., Word, PowerPoint and Excel).
A good knowledge of the overall Clinical Trial process
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.