Computer Systems Validation Engineer - Foster City, CA -katalysthls.com

Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met. Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs). Provide support to external and internal audits related to computerized system validation activities.

https://www.indeed.com/job/computer-systems-validation-engineer-0d85543f4c7f5247

Clinical Data Manager - Gaithersburg, MD- katalysthls.com

Performs clinical data management functions in support of clinical studies. Functions to include some or all, but not limited to: data review, protocol review, case report form (CRF) design and creation, CRF review, data entry, database validation, query generation, and validation of study results. Assists in training new employees, including temporary data management personnel.

https://www.indeed.com/job/clinical-data-manager-19d2591e5e03f7ce

Validation Specialist - Titusville, NJ - KatalystHLS.com

Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.

https://www.indeed.com/job/validation-specialist-11fd8862b709beeb

SAS Programmer - Berkeley Heights, NJ - Katalysthls.com

Develop SAS programs for SDTM, Adam, client-defined analysis datasets, Patient Profiles, Tables, Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (Client) Provide technical planning to include overseeing the set-up of key macros and SAS programs. Act as a Lead Programmer for projects Represent Statistical Programming at internal and client meetings

https://www.indeed.com/job/sas-programmer-4ba1517aaeec4842

Senior Statistician - Foster City, CA - katalysthls.com

Provide sound experimental design and data analysis expertise. Author the protocol statistical sections and generate statistical analysis plans and study randomization. Review and sign-off on relevant study documents and data management and programming deliverables. Prepare mockup tables, figures and listings.

https://www.indeed.com/job/senior-statistician-d166a39817377794

Marketing Business Analyst - Cambridge, MA - http://katalysthls.com/

This is not so much an IT-Business Analyst role, more of a Brand Insights/Marketing based Business Analyst Role Candidate must be willing to learn and interested in Oncology. Pharma experience is an absolute must. 2-4 years minimum experience in Pharma industry as an Analyst. Candidate would serve as Brand Insights Analyst for the Iclusig (50%) and Ninlaro (50%) brand teams. It is essential that s/he have experience working in the Pharmaceutical Industry (Oncology preferred) with strong secondary data analytics experience. Experience using patient claims and specialty pharmacy Rx data preferred.

https://www.indeed.com/job/marketing-business-analyst-b8c0d9cedebe8745

Associate Director, Toxicologist - Stamford, CT - KatalystHLS.com

Associate Director, Toxicologist - Stamford, CT Katalyst HealthCares & Life Sciences KatalystHLS.com ------------------------------------------------------- Primary Responsibilities: To oversee the conduct of general toxicity and drug safety studies in accordance with current scientific and applicable regulatory standards (ICH, FDA) and GLPs and will monitor safety studies related to drug registration. The incumbent will be specialized in general safety evaluation including carcinogenicity evaluation and may have experience in one or more of the following areas genetic toxicology, safety pharmacology, reproductive toxicology. #toxicology #pharmacology #drugsafety #KatalystHLS

https://www.indeed.com/job/associate-director-toxicologist-7927c790cceec664