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.





STATISTICAL PROGRAMMER





Job Description:

  • Develop, validate & support SAS programming for analysis, management & reporting of clinical data and creation of SDTM/ADaM data specifications.
  • Create clinical study protocols and CRF.
  • Perform statistical analyses & generate TFLs to present analysis results.
  • Produce analysis datasets for FDA submission.


Qualifications:

  • B.S. or M.S. in Statistics, Biostatistics, Mathematics, Computer Science, Life Science, or other related fields.
  • 0-1 year working experience in statistical SAS programming for the analysis of clinical data in pharmaceutical, biotech, or CRO.
  • Have knowledge of pharmaceutical industry data standards such as CDISC SDTM and ADaM and produce the SDTM and analysis datasets to meet these data standards.
  • Understand regulatory, industry, and technology standards and requirements and follow the standards and requirements to produce assigned deliverables.
  • Good communication and writing skills and ability to work in a team environment.


Please send your resume to info@deltamedsolutions.com



Statistical Intern





Perform statistical programming using SAS and/or other statistical software packages to support statistical analysis of clinical data for submission to regulatory agencies.


Job Description:

  • Learn the basic knowledge on clinical trial including new drug development
  • Familiarize the process and tools in data management, statistical data analyses and reporting
  • Learn advanced clinical SAS programming
  • Work on clinical projects in dataset mapping spec development, dataset creation, validation and table/figure/listing creations


Qualifications:

  • B.S. or M.S. in Statistics, Biostatistics, Mathematics, Computer Science, or other related fields
  • Prior experience in statistical SAS programming is preferred
  • Have understanding of clinical trial development
  • Good communication and writing skills and ability to work in a team environment.



Please send your resume to info@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 info@deltamedsolutions.com



Bioinformatics Scientist






Job Duties:

  • Develop bioinformatic methods to process and analyze clinical trial data, including but are not limited to biological data and genomic data
  • Generate biological data and genomic data results through project reports including derived analysis datasets, tables, figures, and listings (TLFs) using bioinformatics tools
  • Participate in clinical trial research and provide scientific foundation and suggest feasible solutions and data analysis strategies for each clinical trial, using BLAT, ClustalW, GenBank, SAS and R
  • Publish the latest research and development outcome from research samples and/or trial data analysis reports in conferences and journals as needed
  • Keep abreast of new instruments or software by reading scientific literature and attending professional conferences
  • Confer with other department such as marketing, business development or operations, to coordinate product development and/or improvement


Job Requirements:

  • Doctorate degree in plant pathology, molecular biology or a related field.
  • Must have at least 12- month experience in applications of bioinformatic tools to analyze the biological and genomic data.
  • Must be proficient in analyzing biological data using analytical and scientific software, including BLAT, ClustalW, GenBank, SAS and R.
  • Must have knowledge of preparing analysis datasets, and creating table, figures and listings (TFLs) for the biological samples and genomic data.



Please send your resume to info@deltamedsolutions.com



Statistical Analyst





Job Description:

  • Develop and validate complex statistical models & SAS programs for managing, analyzing, interpreting & reporting of large-scale clinical data.
  • Provide analysis of cross-sectional and longitudinal data and validate clinical trial reports.
  • Create and validate analysis datasets and TLFs.


Qualifications:

  • Master's degree/equiv. in Applied Statistics, Biostatistics, Mathematics or related
  • strong skills in clinical data analysis and reporting for drug development & FDA submission using SAS techniques
  • SAS Advanced Programmer Certificate.


Please send your resume to info@deltamedsolutions.com



Manager of Statistical Programming





Job Description:

  • Produce derived analysis datasets, tables, listings and figures (TLFs) based on the Statistical Analysis Plan (SAP) of the clinical study using SAS, and draw conclusions or make predictions, based on data summaries or statistical analyses.
  • Produce figures using other statistical software such as S‐plus.
  • Create SAS Macros to produce output efficiently as needed and implement data analysis algorithm.
  • Generate data definition tables (DDTs) and analyze clinical or biological data, using statistical approaches such as longitudinal analysis, mixed-effect modeling, logistic regression analyses, and model-building techniques.
  • Produce derived analysis datasets to meet CDISC SDTM and ADaM data standards.
  • Understand and follow DELTAMED internal or client programming standards, and provide biostatistical consultation to clients or colleagues.
  • Review the clinical study protocol, case report form (CRF), and SAP and understand the clinical study design.
  • Write detailed analysis plans and descriptions of analyses and findings for research protocols or reports.
  • Communicate data, statistical, and/or programming issues with internal and external (client/sponsor) programmers, statisticians, and clinical team members.
  • Analyze archival data and make recommendations to management team as needed.

Job Requirements:

  • Master’s degree in pharmaceutical chemistry or chemical statistics, or its foreign equivalent.
  • At least 24 months’ statistical programming experience with health or biotechnology industry is required.
  • Must be proficient in using SAS programming to generate and validate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
  • Must be familiar with CDISC SDTM and/or ADaM standards.


Please send your resume to info@deltamedsolutions.com



Statistical Analyst II





Job Description:

  • Generate biological data and genomic data results through project reports including derived analysis datasets, tables, listings and figures (TLFs) based on the Statistical Analysis Plan (SAP) of the clinical study using SAS.
  • Produce figures using other statistical software such as S-plus, generate data definition tables (DDTs), and create SAS Macros to produce output efficiently as needed.
  • Determine whether statistical methods are appropriate based on the needs of the research projects produce derived analysis datasets to meet CDISC SDTM and ADaM data standards.
  • Understand and follow DeltaMed Solution’s internal or client programming standards.
  • Review the clinical study protocol, case report form (CRF), and SAP and understand the clinical study design.
  • Provide strategy and guidance, as well as hands on support, with clinical assay development and validations for clinical testing to ensure a consistent approach to analyses that meets regulatory requirements.
  • Confer with other departments to coordinate product development and/or improvement.
  • Communicate data, statistical, and/or programming issues with internal and external (client/sponsor) programmers, statisticians, and clinical team members.
  • Present statistical and non-statistical results using charts, bullets, and graphs in meeting or conference to internal team members, clients, and sponsors.

Job Requirements:

  • M.S. in Applied Statistics, Biostatistics, Mathematics, Computer Science, or other related fields.
  • Have knowledge of pharmaceutical industry data standards such as CDISC SDTM and ADaM and produce the SDTM and analysis datasets to meet these data standards.
  • Have understanding of regulatory, industry, and technology standards and requirements and follow the standards and requirements to produce assigned deliverables.
  • Ability to work in a team environment.
  • High proficiency in Microsoft Office, PowerPoint, and Excel Spreadsheet.
  • Excellent oral and written communication skills.
  • Strong ability in handling multi-tasks within set time frame.
  • Strong ability in identifying complex problems, evaluating options, and implementing solutions.

Please send your resume to info@deltamedsolutions.com



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


CONTACT INFO





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



Phone number: (908) 223-8823



Email: info@deltamedcro.com



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