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Sr. Manager, Statistical (CDISC) Programming Full-time

at Katalyst Healthcares & Life Sciences New Jersey in New Jersey (Published at 16-11-2022)

Responsibilities:
  • Serves as functional lead, providing support and sharing technical expertise with other functions, especially the clinical/research scientists engaged in the scientific aspects of the clinical development study/project(s).
  • Serves as lead study programmer on one or more clinical trials, ensuring the accuracy and reliability of reported results, both internally and external to the company.
  • Responsible for the development, review, validation, and execution of SAS programs to generate presentation ready TFL outputs, as defined in the SAP, for regulatory submissions and publications.
  • Provides CDISC data standards expertise, support and advice internally, working primarily with the Data Management and Statistics study team members.
  • Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standard (custom study specific) datasets as defined in the SAP and other specifications documents.
  • Responsible for reviewing and providing input on key study-related documents such as the SAP and TFL specifications (mock-ups/shells), as well as documents produced by other functions, such as case report forms, data management and review plans, and data transfer specifications.
  • Responsible for contributing to all appropriate eSubmission aspects of the study, successfully creating the standard structure for human clinical trial data tabulations and the inclusion of that data in eSubmissions to regulatory authorities. Ensures eSubmission-related processes are compliant with applicable regulatory requirements. These responsibilities shall include but are not limited to:
  • Provides input into the selection of CROs/contractors from an eSubmission perspective in conjunction with the study team and corporate headquarters.
  • Providing input to eSubmission related documents, e.g., Study Data Reviewer's Guide (SDRG), Analysis Reviewer's Guide (ADRG), define.xml and Study Data Standardization Plan (SDSP).
  • Reviewing and approving CROs' study documentation for eSubmission.
  • Actively seeking internal feedback while monitoring the performance and quality of on-going programming work performed by CROs by reviewing the appropriate documentation and by developing internal programs for validation oversight purposes, ensuring that the CROs meet the agreed study plan, contracts and any study specific requirements and timelines within all appropriate eSubmission aspects of the study(s).
  • Ensures that data packages meet the required standards for submission to regulatory agencies
  • Provide hands-on programming as per study needs, post-hoc analyses, and rapid response to inquiries by regulatory authorities in a timely manner.
  • Responsible for effective and timely communication within the company and to external organizations for successful completion of submission related activities.
  • Conducts oneself at all times in accordance with client's Quality Management System, working practices and Good Clinical Practice/Good Manufacturing Practice regulations, and ensure training in these areas is kept up to date at all times.
  • Serves and participates on global task forces and/or working groups, involved in developing global programming standards and/or related processes.
  • Authors or contributes to the development of Standard Operating Procedures (SOPs) and standard documents related to the implementation of programming standards and eSubmission, as required.
  • Ensures knowledge transfer throughout and upon completion of the study/project.
  • Remains current on regulatory changes to the eSubmission process as it applies to Clinical Development. Implement new ideas and processes where applicable.
  • May be required to perform other duties, as assigned.
Requirements :
  • Bachelor's degree in Computer Science, Information Technology Systems, Statistics, Biostatistics, Mathematics, Biometrics, Engineering or a related scientific discipline, or equivalent in work experience.
  • At least five (5) years demonstrable programming and/or data analysis experience gained within a pharmaceutical or biotechnology industry or in a contract research organization (CRO). Preferrable to have worked in a global environment.
  • FDA and NDA submissions Packages Experience 2
  • Possesses subject matter expertise on CDISC data standards and proven experience working with CDISC compliant data.
  • At least two (2) years of SDTM and ADaM lead experience in the pharmaceutical industry.
  • Demonstrated knowledge of clinical drug development process
  • Thorough knowledge of regulatory requirements for data submissions, specifically the standard structure for human clinical trial data tabulations to be submitted to the regulatory authorities.
  • Demonstrated proficiency with ICH/GCP guidelines, related programming practices and knowledge of other regulatory guidelines relating to eSubmission.
  • Demonstrable experience utilizing the Electronic Common Technical Document (eCTD) format for regulatory submissions of applications, amendments, supplements and reports to regulatory authorities.
  • Experience working individually as well as collectively in a collaborative multi-cultural team environment, under time and resource pressures.
  • Ability to handle multiple tasks, with competing priorities.
  • Possesses strong organizational skills, with an ability to manage time and resources to ensure the successful achievement of pre-determined deadlines
  • Flexibility in approach, while ensuring the delivery of high-quality work in a dynamic work environment.
  • Ability to oversee and manage a CRO's CDISC and ADaM dataset related activities and table/figure/listing programming activities of assigned clinical trials.
  • Able to interact effectively at all levels within the organization, as well as with external partners and clients.
  • Must have excellent communication and presentation skills (written and verbal).
  • Demonstrated ability to effectively interact with internal team members and external parties that do not possess the knowledge and background to readily understand the application of programming practices to drug development and study outcomes.
  • Strong analytical and problem-solving skills.
  • Utilizes a methodical and detailed approach in the review and consideration of procedures and data, without losing sight of the bigger picture.
  • Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources for meeting all pre-determined timelines and outcomes.
  • Requires strong programming skills in SAS, with SAS Certification preferred; R programming skills are preferable.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.
  • As our client is a global company, this role may be required to attend and participate in business meetings in person or via conference all that will be scheduled in the evening or early morning.
  • This role requires the incumbent to travel, which will be primarily domestic. However, the incumbent may have to occasionally attend meetings at client's Corporate Headquarters in Japan. Travel will be scheduled based upon the needs of the business, up to 10% of the time.


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