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CAREER OPPORTUNITIES



Deltamed Solutions Inc. is seeking highly motivated individuals to join our team and further our mission in clinical trials. The successful candidate will be part of a fast-paced and highly collaborative team.





Clinical Data Manager II





Job Description:

  • Understand and adhere to the data processing necessities per study protocol and data management documentation
  • Monitor and maintain EDC training and access records
  • Perform study EDC user acceptance testing of studied programmed in various EDC systems
  • Communicate and answer the data entry questions from study sites per eCRF Completion Guidelines (eCCGs)
  • Validate clinical trial data write, process and close queries per Data Validation Plan (DVP)
  • Create study metrics reports (e.g. enrollment, CRFs, etc.) and coordinate with SCDM to provide the reports to the team to monitor study progress
  • Generate and distribute study data listings to the team for review per Data Management Plan (DMP) and other specifications
  • Assist to develop and maintain data transfer agreements and specifications with external vendors
  • Coordinate with study team to resolve data discrepancies identified from external data reconciliation (e.g. SAE, Labs)
  • Prepare, as needed, the study material for investigator, data review and project meetings
  • Contribute and participate in the new initiatives to improve functions or processes for the data management activities
  • Adhere to the standard operational procedures and ensure appropriate documentation for areas of responsibility


Job Requirements:

  • BS/BA degree or equivalent in a relevant scientific discipline
  • Minimum of two years experience in industrial experience at pharmaceutical company or Clinical Research Organization (CRO)
  • Hands-on experience in Data Management activities
  • Good communication skills are a must
  • Attention to details and quality driven
  • Knowledge and experience in Electronic Data Capture (EDC)
  • Knowledge in Data Visualization tools like Spotfire, JReview etc.


Please send your resume to kelly.lupo@deltamedsolutions.com



Senior Statistician





Job Description:

  • Provide statistical expertise in clinical trials and collaborate with Clinical Research and Medical Writing groups on clinical trial protocols, case report forms, statistical analysis plans and other study related documents
  • Provide guidance to study statistician in SAP writing, statistical analysis and derived analysis datasets and ensure the accuracy and quality of the statistical analysis output
  • Generate and interpret statistical reports, tables, figures, and statistical sections of clinical study reports
  • Manage study resources and timeline and ensure the quality delivery of the analysis results in a timely fashion
  • Provide statistical expertise and advice for submission of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
  • Have in depth knowledge of FDA, EMEA, and ICH guidelines and regulations and in industry data standards, e.g., CDISC, SDTM, and ADAM
  • Collaborate closely with cross-functional teams, including biostatisticians, data managers, and clinical operations, to ensure the delivery of high-quality statistical analyses and data insights
  • Mentor and provide guidance to junior statisticians, statistical analysts, and other team members

Job Requirements:

  • M.S. or PhD in Statistics or Biostatistics
  • 5+ years for M.S. or 3+ years for PhD of experience in clinical trials for regulatory submissions in pharmaceutical, biotech, or CRO environment
  • Excellent analytical and problem-solving skills
  • Excellent communication and writing skills
  • Good programming skills in SAS, S-plus or other statistical software
  • Ability to work in a team environment
  • Demonstrated ability to lead and manage statistical activities for multiple clinical trials or research project


Please send your resume to kelly.lupo@deltamedsolutions.com



BIOSTATISTICIAN





Job Description:

  • Provide statistical expertise in clinical trials and collaborate with Clinical Research and Medical Writing groups on clinical trial protocols, case report forms, statistical analysis plans and other study related documents.
  • Provide guidance to study statistician in SAP writing, statistical analysis and derived analysis datasets and ensure the accuracy and quality of the statistical analysis output.
  • Provide statistical expertise and advice for submission of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.
  • Apply statistical methodology to clinical trials in multiple therapeutic areas across multiple phases (I-IV).
  • Perform statistical analyses and generate TFLs to present analysis results.


Qualifications:

  • Ph.D. or M.S. in Statistics, Biostatistics, Life Sciences, or other related field.
  • 0-1 year working experience of experience in clinical trials for regulatory submissions in pharmaceutical, biotech, or CRO environment.
  • Strong skills in SAS programming and statistical analysis of clinical trials data.
  • Solid knowledge of clinical study design and data standard (CDISC SDTM & ADaM).


Please send your resume to kelly.lupo@deltamedsolutions.com



EQUAL OPPORTUNITY EMPLOYER STATEMENT



DeltaMed Solutions is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, or veteran status.


We take pride in our commitment to fairness and transparency in our recruitment practices. Our job postings are crafted using accessible and non-discriminatory language to attract a diverse pool of candidates. Additionally, we conduct internal audits to ensure compliance with EEO laws and regulations.



ABOUT US





A growing CRO with a global footprint in U.S. and China


Building strategic partnerships or preferred vendor relationships with pharmaceutical companies, biotechnology companies and CROs


Flexible service models with experienced staff to deliver high quality products for your CSR, regulatory submission, or publication


Full commitment to excellence with our expertise, experience and passion to enable you to get to market faster, reducing time and cost



THERAPEUTIC AREA EXPERTISE





  • Oncology Immunology/Autoimmune
  • Rare Disease/Orphan Drug
  • Anti‐Inflammatory/Pain
  • Neurology/CNS
  • Cardiovascular
  • Gastroenterology
  • Ophthalmology
  • Allergy
  • Vaccine
  • Anti‐Infective
  • Diabetes & Metabolic Disease
  • Cell & Gene Therapy
  • Endocrinology
  • Infectious Disease/Vaccine


CONTACT INFO





Address: 220 Davidson Ave, Suite 201, Somerset, NJ 08873


Phone Number: (908) 223-8823


Email: info@deltamedsolutions.com


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Copyright © 2020 DeltaMed Solutions, Inc. | All Rights Reserved.