K3-Innovations, Inc. | LEAD STATISTICAL PROGRAMMER | telangana

2 weeks ago

telangana, India K3-Innovations, Inc. Full time

Responsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions. Works closely with Biostatisticians and Data Managers to support creating SAS programs for independently validating tables, listings, and figures produced by programming vendors, for ad-hoc analyses, and to assist with data cleaning and query generation. Independently produces selected SDTMs/ADaM/TFLs for analysis preparation and for validation. Serves as a contact for programming activities being performed at assigned CROs.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Provides SAS programming support to all clinical studies.
  • Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables.
  • Provide statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
  • Provides primary programming and QC support for any internally produced outputs.
  • Reviews and approves SAS programming instructions and CDISC/ADaM specifications.
  • Performs statistical analysis and simulations using SAS to support clinical trial design and data interpretation.
  • Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming.
  • Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming.
  • Works closely with biostatisticians and other functions (Pharmacovigilance, Clinical Development, etc.) to support data review for internal stakeholders.
  • Assists with ensuring consistency across programming methods in similar studies within a program.


JOB QUALIFICATIONS:

Education, Certifications, Experience:

  • Bachelor’s Degree or Master’s degree or higher in statistics, biostatistics, or other closely related discipline with a minimum of 8 years of relevant experience in the pharmaceutical/biotechnology industry
  • Experience in applying clinical trial and statistical methodology to a variety of studies and indications across various phases of clinical development


Knowledge, Skills and Abilities:

  • Knowledge of pharmaceutical and regulatory requirements, procedures, and policies.
  • Experience with BLA or NDA/sNDA submissions is required.
  • Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
  • In depth knowledge of CDISC and ADaM data set structures and requirements
  • Proficiency with SAS programming skills to including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL) Knowledge of all aspects of clinical drug development (Phase 1-4)
  • Experience working with a CRO partner.
  • Excellent computer skills; strong verbal and written communication skills
  • Ability to work well in a team environment as a contributor.
  • Open, engaging, and transparent work style
  • Ability to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a very fast-paced environment

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