Curis is seeking a talented SAS Programmer/Data Manager to support multiple clinical studies. The position demands understanding of data management, study design, statistical summaries, and research milestones in a rapidly changing environment.
• Build SAS datasets from clinical databases
• Receive data from external sources and build SAS datasets for analysis
• Work with other functional groups to ensure programming aspects of projects are properly considered and integrate well with other activities
• Develop normalized laboratory data files
• Write SAS programs to generate tables, listings, and figures and analysis datasets
• Validate the programmed analysis datasets, tables, listing and figures
• Perform quality control on final output
• Develop SAS coding and table templates for preparing, processing and analyzing clinical data
• Establish monitoring of data transfers for ongoing trials to identify study conducts or data quality issues
• Preparation of safety listings for ad hoc/periodic analysis and routine safety data monitoring for reviews
• Preparation of data listings to support periodic and development regulatory activities (e.g., FDA Annual Reports, DSURs)
• Collection/management/archiving of clinical study databases from completed studies; provision of SAS datasets for regulatory submissions
• Prepare TLFs as needed
• Support Clinical Operations with management of DM vendors including development and maintenance of Clinical Data Management Plans, CRF completion guidelines, Statistical Analysis Plans, etc.
• Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy
• Review CRF annotations and data specifications
• Define processes for data management compliance
• Establishes and maintains a working environment which fosters open communication, collaboration, integration, and teamwork
• Bachelor of Science Degree (health-related field preferred). Clinical SAS programming experience may substitute for the post-secondary educational requirement.
• At least 5-7 years combined SAS programming and data management experience in the pharmaceutical, biotechnology, or contract research organization industries
• PL/SQL programming experience is preferred
• Previous experience with EDC required
• Overall understanding of ICH GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials and clinical research
• Knowledge of CDISC, SDTM and ADAM
• MedDRA and WHO Drug coding proficiency helpful
• Basic knowledge of statistics helpful
• Excellent interpersonal, communication and organizational skills with the ability to work independently and in a team environment
• Complex problem solving skills
• Solid vendor management skills
• Ability to adapt and adjust to changing priorities
• Ability to prioritize activities and multi-task across various projects that will be at different study stages
• Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
Please send CV with job code (PDM500) to:
Human Resources, Curis, Inc.
No phone calls please.
Curis, Inc. is an Equal Opportunity Employer.
Curis is a publicly-traded biotechnology company (NASDAQ: CRIS) focused on the development and commercialization of innovative drug candidates for the treatment of human cancers.
Curis’s most advanced drug candidate is CUDC-907, an orally-available, small molecule inhibitor of histone deacetylase, or HDAC, and phosphatidylinositol-3-kinase, or PI3K enzymes. Curis is currently investigating CUDC-907 in a Phase 2 clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL with alterations in the MYC oncogene. Curis is also conducting a Phase 1 study of CUDC-907 in patients with solid tumors, and has recently directed efforts in this study to enroll patients with MYC oncogene involvement, including patients with NUT midline carcinomas, or NMC.
In addition, Curis is party to an exclusive collaboration agreement focused on immuno-oncology and selected precision oncology targets with Aurigene Discovery Technologies Limited, or Aurigene, a specialized, discovery stage biotechnology company and wholly-owned subsidiary of Dr. Reddy’s Laboratories (NYSE: RDY). In October 2015, Curis exercised options to license the first two programs under this collaboration. The first licensed program is focused on the development of orally-available small molecule antagonists of PD-1 and VISTA in the immuno-oncology field, including the development candidate currently being investigated in Phase I clinical trials, designated CA-170. The second licensed program is focused on orally-available small molecule inhibitors of Interleukin-1 receptor-associated kinase 4 (IRAK4) in the precision oncology field. In addition, in October 2015 the Company selected a second preclinical program within the immuno-oncology field that is focused on evaluating small molecule antagonists with dual PD-1 and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) targeting properties. Curis expects to file an IND and initiate Phase 1 clinical testing of the IRAK4 inhibitor in 2016.
Curis’ other collaborators, F. Hoffmann-La Roche Ltd, or Roche, and Genentech Inc., or Genentech, a member of the Roche Group, are commercializing Erivedge® (vismodegib), a first-in-class orally-administered small molecule Hedgehog signaling pathway inhibitor, in advanced basal cell carcinoma, or BCC. Roche and Genentech are also continuing Erivedge’s clinical development in less severe forms of BCC, and have recently initiated clinical studies of Erivedge in idiopathic pulmonary fibrosis, or IPF, and myelofibrosis.
Our corporate culture is focused on learning and growing in a challenging environment with a committed group of peers working together as a team. For more information, visit Curis' website at www.curis.com.