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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.





Statistical Analyst





Statistical Analyst (2 x Openings) in Somerset, NJ


Job Description:

  • Develop and validate statistical models and SAS/R programs for analysis, management and reporting of large-scale clinical data.
  • Perform a wide range of analytics tasks, including predictive modeling, machine learning and statistical analysis, to derive actionable insights from data.
  • Develop and maintain data structures and databases to support ongoing clinical study projects and reporting needs.

Job Requirements:

  • Master's degree/equiv. in Statistics, Mathematics, Business Analytics or related.
  • Strong skills in programming languages Python, SAS/R, SQL.
  • Solid understanding of statistical analysis, machine learning techniques, data mining and data analytical methods.
  • SAS Base Programmer certificate.


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



FSP Portfolio Manager





Job Description:

  • Serve as the primary point of contact for assigned FSP clients and manage day-to-day interactions
  • Oversee contract execution, scope of work, and compliance with agreed terms
  • Monitor key performance, service level agreements and metrics to evaluate FSP performance
  • Identify areas of improvement and implement corrective actions when performance gaps arise
  • Facilitate regular performance reviews and ensure continuous quality improvement
  • Track project timelines, deliverables, and resource allocation to ensure goals are met
  • Ensure FSP operations adhere to regulatory guidelines, company policies, and industry standards
  • Facilitate clear communication and alignment between FSP teams and internal teams
  • Provide updates to management on FSP performance, progress, and risks.

Job Requirements:

  • B.S or M.S. in Life Sciences, Business, Project Management or relevant field
  • 5+ years of experience managing vendor relationships, outsourcing or clinical operations in pharmaceutical/CRO or biotechnology industry
  • Proven expertise in FSP models within pharmaceutical, CRO, biotechnology, or related industries
  • Strong project management and organizational skills
  • Proficiency in contract and financial management
  • Excellent interpersonal, negotiation, and communication skills
  • Must work well independently and in a team environment
  • Exceptional written and verbal communication skills


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



QA Manager





Job Description:

  • Design, implement and improve company quality standards.
  • Be responsible for company quality process including SOP and other working process.
  • Lead internal quality management including internal quality control audit.
  • Serve as primary point of contact and support for external audit and/or inspection.
  • Collaborate with teams to develop and implement corrective and preventive action plans (CAPAs) in response to audit findings.
  • Facilitate follow-up meetings with clients to discuss the findings, clarify any questions, and agree on timelines for implementing CAPAs.
  • Monitor the implementation of CAPAs and verify their effectiveness in addressing audit findings.
  • Prepare and present detailed audit reports to senior management, highlighting findings, recommendations, and follow-up actions.
  • Lead the preparation of comprehensive audit reports in response to client-initiated audits, ensuring findings are clearly documented, and evidence-based.
  • Analyze data in order to find areas for improvement.
  • Training, motivating, coaching, and correcting employees to ensure that standards are met.
  • Create reports to track progress.
  • Formulate strategies to increase productivity.
  • Review processes in order to ensure that they align with current trends.
  • Stay updated with changes in regulatory standards and guidelines to ensure ongoing compliance.

Job Requirements:

  • B.A. or M.S. in Business or Science
  • 3 to 5 years prior experience in a QA role
  • 2+ years of experience in industry of pharmaceutical, biotech, or CRO environment
  • Prior experience as an Assistant QA Manager is a plus
  • Excellent communication and writing skills, good people interact skills, proficient in MS-Word, Excel or other office/financial software
  • Willingness to assist other departments to develop solutions and metrics
  • Detail oriented


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 info@deltamedsolutions.com



Manager of Business Development





Job Description:

  • Developing in-depth knowledge of company offerings to identify profitable business opportunities.
  • Directing marketing efforts by presenting market research and suggesting strategies to expand market research.
  • Negotiate and close agreements with customers.
  • Assessing marketing and sales as well as supplier and vendor operations and recommending improvements as needed.
  • Preparing all documentation required for requests for proposals (RFPs).
  • Researching emerging trends and recommending new company offerings to satisfy customers’ needs.
  • Developing and managing strategic partnerships to grow business and prepare detailed reports and presentations to the management team on business development activities.

Job Requirements:

  • Bachelor's degree in business administration, marketing, finance, or related field master's degree is a plus.
  • 3-4 years of proven business development, sales, or marketing experience.
  • PHARMACEUTICAL EXPERIENCE IS MANDATORY.
  • Proficient in all Microsoft Office applications.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Exceptional leadership and management skills.
  • Effective communication and negotiation skills.
  • Strong business acumen.
  • Detail-oriented and persuasive.

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



DIRECTOR OF FINANCE





Job Description:​

  • Oversee the financial strategic planning of the company by evaluating its performance and potential risks.
  • Perform regular financial analysis.
  • Develop budgets that meet the requirements of company departments.
  • Supervise all audit and internal control processes.
  • Prepare detailed reports on the company’s financial performance.
  • Guarantee compliance with financial laws and guidelines.
  • Recognize patterns in company spending, revenue, and recommend solutions to any problem areas.
  • Coordinate with external financial entities on behalf of the company.


Qualifications:​

  • Bachelor’s degree in accounting, finance, or relevant field.
  • A minimum of 5 years of experience in financial management.
  • CPA certification is a plus
  • In-depth knowledge of accounting software, corporate principals, and financial analysis.
  • Excellent communication and interpersonal abilities.
  • An analytical mind with good organizational skills.
  • Outstanding leadership skills.


Please send your resume to info@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.