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Biostatistician
Position Duties and Responsibilities Arog Pharmaceuticals, Inc. is a fast-growing oncology-focused biopharmaceutical company located in Dallas, Texas. We are recruiting for a Biostatistician to provide support as the project statistician on a team or within a therapeutic area. For one or more projects, you will be accountable for statistical aspects of protocols and submissions including quality. You will participate in preparation of statistical strategy, implementing study designs, statistical models and analysis methodologies by establishing the efficacy and safety of the drug. Moreover, you will be accountable of overseeing external vendors for outsourced activities with responsibilities related to quality, budgets and timelines related to allocated studies. Specific responsibilities may include, but are not necessarily limited to: • Design clinical trials and provide sound statistical guidance on clinical development projects • Review of study protocol and preparation of statistical methodologies • Provide sample size estimates for proposed studies • Oversee and monitor CRO performance on implementation of SAP • Write statistical section of study protocols, statistical analysis plans and study reports • Review and consult on CRF design • Develop clinical trial randomization • Review study protocols, CRFs, database structures, edit check specifications, analysis plans, study reports and annual reports • Lead study or project team in the review and discussion of SAP • Maintain study documentation of statistical analyses and supportive documents • Other duties as assigned Qualifications: • PhD degree in Statistics, Biostatistics or related field, and at least two years of relevant experience, or Masters degree in Statistics, Biostatistics or related field, and at least four years of relevant experience • At least 3 year’s experience as Statistician in Pharmaceutical industry with experience in ONCOLOGY • Proficient with SAS programming and other statistical software (e.g., R, nQuery) • An ability to be productive and successful in a collaborative work environment • Good communication skills – written and verbal • Excellent interpersonal, verbal and written communication skills are essential • Comfortable in a small to mid-sized company environment with minimal direction and able to adjust workload based upon changing priorities • Extensive knowledge of statistics applied to clinical studies • Demonstrable knowledge of international standards (ICH, GCP, CDISC) and regulations related to clinical studies • Extensive knowledge in management and oversight of external vendors

Company: Arog Pharmaceuticals, Inc.
Contact Person: Mamta Puri-Lechner
Contact E-mail: mpurilechner@arogpharma.com
Phone: 2145930548
Address: 5420, LBJ Freeway
Suite 410
Dallas, Texas 75240
United States
   


Biostatistician Faculty Director
The Rush Institute for Healthy Aging at Rush University invites applications from candidates for tenure track faculty positions at the associate or full professor level to lead analytic and data management activities and staff in a thriving and growing multi-faceted research group with multiple community cohort studies, including epidemiologic studies and behavioral intervention and preventive trials. The successful candidate will also oversee an epidemiology and biostatistics staff for a university-wide core service and data network of the Chicagoland region. Candidates should preferably hold a doctoral degree in biostatistics. The ideal candidate will have demonstrated excellence in research. In addition, Rush University Medical Center has a strong and growing repository of clinical data that has been well organized and characterized, sourced from the Electronic Medical Record. Candidates with an interest in use of Electronic Medical Record data for research are strongly encouraged to apply.

Interested applicants should submit CV and cover letter to:

Company: Rush University Medical Center
Contact Person: Maggie McGauley
Contact E-mail: Maggie_McGauley@rush.edu
Phone: 3129425813
Address: 1725 W. Harrison Street
Suite 964
Chicago, IL 60612
USA
   


Director, Data Coordination and Analysis Center
HJF is seeking a Director, Data Coordination and Analysis Center to support the US Military HIV Research Program (MHRP) located in Bethesda, Maryland. HJF provides scientific, technical and programmatic support services to MHRP. To apply please go to our HJF careers website and search for JOB #212789. The incumbent serves as the lead research analyst supporting the clinical research activities of the MHRP through direction and leadership of the Data Coordination and Analysis Center (DCAC). DCAC provides data collection, management, processing and analytic support to a wide portfolio of research projects executed by MHRP and affiliated organizations including observational and interventional studies. The incumbent is responsible for ensuring the complete and accurate collection of research data from all clinical research sites. The incumbent oversees a staff of programmers, data management specialists, and research analysts that are tasked with the creation and implementation of tools to support data capture, routine monitoring of data for completion and accuracy, communication with clinical research sites to coordinate data entry and response to database queries, preparation of data reports, and design and execution of statistical analyses to test research hypotheses. The incumbent is responsible for directing and coordinating the completion of all responsibilities assigned to DCAC while ensuring that all necessary steps are taken to comply with regulatory requirements and ensure data integrity. Responsibilities: Directs and leads all activities of the MHRP Data Coordinating and Analysis Center (DCAC), supervising a team that includes research analysts, data management specialists, and programmers. Assigns research protocols and delegates related responsibilities to DCAC staff, ensuring that all DCAC staff are aware of their accountabilities, responsibilities and deliverables. Develops and maintains an excellent working relationship with MHRP scientific staff, HJF/MRI, DAIDS/NIH, collaborators, and other organizations. Maintains a team of professionals with sufficient expertise to execute the DCAC mission through identification of personnel needs, recruitment and retention of highly-qualified staff, and provision of performance evaluation feedback. Evaluates and acquires tools to optimize data collection and analysis as needed. Monitors the accuracy and completeness of data included in MHRP research databases and develops systems to enhance the integrity of these data. Provides relevant program status reports to the institution, regulatory agencies, funders, and other entities. Designs and implements statistical analyses in consultation with MHRP investigators and collaborators. Contributes to the preparation of scientific papers for presentation at local and national meetings and for publication in medical and scientific periodicals. Adheres to a

Company: Henry M. Jackson Foundation
Contact Person:
Contact E-mail:
Phone:
Address: 6720A Rockledge Drive, Suite 100
Bethesda, Maryland 20817
United States
   


Faculty Position in Cancer Center Statistics- Rochester, MN
Heal the sick, advance the science, share the knowledge. MAYO CLINIC is a premier academic medical center with over 3,800 physicians and scientists in a unified multi-campus system. This unique environment brings together the best in patient care, groundbreaking research and innovative medical education. Mayo Clinic has been recognized as the best hospital in the nation for 2018-2019 by U.S. News and World Report. We are an integrated, multidisciplinary academic medical center with comprehensive programs in medical education and research that span across three group practice sites. We support a vibrant research enterprise and graduate school with a dedicated track in virology and gene therapy. In 2017, the institution received over $446 million in extramural research awards supplemented with over $304 million of institutional support. Mayo Clinic has a large number of outstanding laboratories and shared resources facilities, including a Viral Vector Production and preclinical Toxicology Core, Medical Genomics Facility, a Mouse Modeling Facility, Molecular and Microscopic Core Facilities, and unique Human Disease Tissue Banks. The Division of Biomedical Statistics and Informatics in the Department of Health Sciences Research at Mayo Clinic is seeking applications for a faculty position in the Section of Cancer Center Statistics. The Section of Cancer Center Statistics, within the Division of Biomedical Statistics and Informatics, houses the Biostatistics Shared Resource of the Mayo Clinic Cancer Center and the Statistical and Data Center for the Alliance for Clinical Trials in Oncology. The Section has provided expert statistical collaboration with cancer investigators for over 35 years and has a rich tradition of methodological research in clinical trials, survival analysis, surrogate endpoints, quality of life methods, and high dimensional data. It currently houses 12 PhDs, 19 master’s Statisticians, and 27 bachelors-trained statisticians. Candidates should have a PhD in Biostatistics or a closely related field with demonstrated experience and interest in clinical trials and/or patient reported outcomes/quality of life methods. ©2018 Mayo Foundation for Medical Education and Research. Post offer/pre-employment drug screening is required. Mayo Clinic is an equal opportunity educator and employer (including veterans and persons with disabilities).

Company: Mayo Clinic
Contact Person: Mariano Vassallo
Contact E-mail: Vassallo.Jesus@mayo.edu
Phone: 0000000000
Address: 200 1st Street SW
Rochester, Minnesota 55905
United States
   


PhD Biostatistician
The Division of Pediatric Critical Care in the Department of Pediatrics at the University of Utah School of Medicine is recruiting a PhD Biostatistician. The Biostatistician will play a leadership role in study design and in the analysis and interpretation of data collected in clinical trials, prospective cohort studies, and other ongoing investigations in the Data Coordinating Centers and Intermountain Injury Control Research Center within Pediatric Critical Care. In addition to this important role on several multicenter research networks, this individual may be asked to work with study design and data interpretation for other members in the Department of Pediatrics as needed and as available (although the primary focus of this position will be within the Centers). Qualified candidates must have a PhD in Biostatistics or Statistics and experience as a biostatistician in clinical trials, cohort studies and/or research networks. Excellent communication skills with both statistical and non-statistical audiences is vital. The selected candidate will receive a faculty appointment in the Department of Pediatrics on the Research or Tenure Track at the academic level commensurate with experience and qualifications. The University offers a competitive salary and an unmatched benefits program, including non-contributory retirement contributions of 20.2% of annual salary that vest immediately. The Department offers an education loan repayment program, in addition to a faculty development and mentoring program. Interested individuals can read more about the position and apply at utah.peopleadmin.com/postings/70367. Cover letter and curriculum vitae will be required. For additional information about the position, please contact: Rich Holubkov, PhD, Professor at rich.holubkov@hsc.utah.edu. The University of Utah is an Equal Opportunity/Affirmative Action employer and educator.

Company: University of Utah
Contact Person: Shauna Maxwell
Contact E-mail: tricia.westbrook@hsc.utah.edu
Phone: 8015877406
Address: 201 S Presidents Cir
Salt Lake City, Utah 84112
United States
   


Senior Program Manager
The ISAC Senior Program Manager will work with Directors in establishing/growing all aspects of this new Center and provide support to investigators conducting clinical trials with the assistance of ISAC. This is an exciting and visible opportunity for an experienced professional to be a key contributor in one of the leading research institutes in the field of aging. Responsibilities include program development/project management related to human investigations in aging. Responsibilities • Manage key administrative processes for ISAC, coordinate Director/Center meetings, agendas and subsequent action items • Coordinate communications and outreach for ISAC activities within IFAR, HSL and outside HSL • Coordinate consultation services provided by ISAC faculty and staff to investigators • Maintain and update ISAC online textbook related to the design and conduct of clinical trials • Update and maintain ISAC website • Manage solicitation and administrate pilot studies • Coordinate ISAC seminars and teaching workshops • Guide investigators through clinical trials project management and regulatory issues. • Collaborate with ISAC team on development and testing of data capture, management and analysis tools • Lead by example by serving as project manager on one or more active projects Qualifications • Minimum 5 years of experience managing and executing operations for large clinical trials, preferably multi-site investigations in older populations • Advanced degree (e.g., Master’s, PhD, MD) in clinical research, medicine, nursing, psychology, sociology, epidemiology or related discipline • Certified in Good Clinical Practice; comprehensive understanding of regulatory requirements in human subjects research; familiarity with ICH guidelines, 12 CFR Part 11 and other relevant regulatory requirements • Experience with IND applications and interactions with the FDA is preferable • Solid knowledge/experience in state-of-the-art clinical trial project management • Collaboration, independence, entrepreneurship, ambition, pragmatism, oral communication to scientific/lay audiences, excellent English writing • Outstanding organizational skills; ability to lead, take instruction and adapt to change • Independent thought and ability to execute and share ideas with confidence www.careers-hebrewseniorlife.icims.com/jobs/2360/project-director-iii-program-manager-iii---interventional-studies-in-aging-center-%28isac%29-at-the-institute-for-aging-research/job

Company: Institute for Aging Research, Hebrew SeniorLife
Contact Person: Erin Luers
Contact E-mail: ifarcareers@hsl.harvard.edu
Phone:
Address: 1200 Centre St
Roslindale, Massachusetts 02131
United States
   

 

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