Current Openings

Statistical Programmer

The Statistical Programmer will play a lead role in supporting the statistical analysis and reporting of data from clinical and nonclinical studies.

QUALIFICATIONS:

  • Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.
  • Minimum of 4 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
  • Demonstrate extensive knowledge of CDISC SDTM and ADaM data structures and controlled terminology, and FDA guidances and technical conformance guides covering the electronic submission standardized study data.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.
  • NDA submission experience is a plus.

Clinical Data Manager

PRIMARY OBJECTIVE OF THE POSITION:

The primary objective of the Clinical Data Manager is to coordinate and complete in-house data management activities to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting.

QUALIFICATIONS:

  • A scientific background (BS degree or higher) with 3-5 years of clinical data management experience in the pharmaceutical/biotechnology industry.
  • Be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across various projects that will be at different study stages. MedDRA and WHO Drug coding proficiency is preferred.
  • Previous experience with reviewing data and database validation for EDC (DSG’s eCaselink is preferred) is required.
  • Knowledge of CDISC/SDTM standards is also highly desired.

Clinical Project Manager

The primary duties of this position are to provide project management and leadership to plan, prepare and execute high quality clinical trials.  Ensures that all clinical activities related to one or more clinical trials are managed effectively in support of regulatory submissions and subsequent approval of dermatological drugs and devices.

QUALIFICATIONS:

  • Bachelor’s-level degree required in science/health related field. A Master’s degree is preferred.
  • The candidate should have a minimum of 5 years clinical research and/or clinical project management experience.
  • A thorough understanding of GCPs and FDA and ICH guidelines is essential.
  • Excellent written and oral communication skills, the ability to manage multiple priorities and attention to detail are critical.

Clinical Research Associate – SD Based 

PRIMARY OBJECTIVE OF THE POSITION:

The primary objective of the Clinical Research Associate is to monitor clinical studies for Therapeutics, Inc. to ensure the studies are conducted in compliance with current applicable federal, state, local and corporate regulations and procedures [including Good Clinical Practices (GCP) and International Conference on Harmonization (ICH)]. A secondary objective is to ensure clinical study schedules and budgets are met.  This position will require 60-80% travel.

MAJOR RESPONSIBILITIES AND DUTIES:

The Clinical Research Associate must manage clinical study sites to ensure subject safety and compliance with the study protocol, timeline and budget,  in support of on time and within budget regulatory submission.

QUALIFICATIONS:

  • Bachelor’s degree in a science-related background and at least 2 years’ experience in clinical research monitoring or a combination of education and experience that indicates the ability to perform the tasks associated with the Clinical Research Associate position.
  • A knowledge/understanding of the principles of clinical research and drug development is desired but not essential.

Excellent written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical.


Biostatistician

PRIMARY OBJECTIVE OF THE POSITION:

The primary objective of the Biostatistician is to provide statistical expertise in the design and analysis of clinical studies, as well as the interpretation and reporting of the results.

QUALIFICATIONS:

·         A masters or doctoral level degree in statistics with at least 3 years of experience performing statistical analysis and reporting for clinical trials.

·         A thorough understanding of the requirements of the management and analysis of clinical data as required by GCPs, FDA and ICH guidelines is essential.  

·         Excellent problem solving, organizational, written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical.  

·         Computer proficiency and SAS programming skills are required.

·         Understanding of SDTM and ADaM standards.

·         Ability to perform statistical analyses of clinical data, prepare written interpretations of statistical results and to integrate these findings into clinical study reports and publications.

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