Clinical Trials Biostatistician cum Statistical Programmer Associate Manager

2 days ago


Bengaluru, Karnataka, India Biocon Biologics Full time

Biostatistician cum Statistical Programmer

We are seeking a highly skilled Clinical Trials Biostatistician cum Statistical Programmer to join our team as an Associate Manager. In this role, you will be responsible for performing biostatistical and SAS programming activities for various clinical trials involving novel, biosimilar, and PMS studies.

About the Role

  • You will work on a variety of projects, collaborating with our cross-functional team of experts to develop statistical skills, gain exposure to multiple therapeutic areas, and contribute to research design and analytical strategies.
  • You will also provide input into protocols, statistical methodology, and develop and review statistical analysis plans.
  • In addition, you will leverage your SAS programming skills to support Phase I-IV clinical trials, with expertise in CDISC implementation (SDTMs, ADaMs) & TFLs, and experience in regulatory submissions.

Your Responsibilities

  1. Provide SAS programming support to all clinical projects (Phase 1 to 4), manage programming CROs, and create programming-related SOPs as necessary.
  2. Work with CRO's Biostatistics and SAS Programming and Data Management teams on various clinical projects, providing statistical input into and reviewing statistical deliverables.
  3. Perform data manipulation, analysis, and reporting of clinical trial data, utilizing SAS programming, creating and validating datasets/analysis files, tables, listings, and figures (TLFs).
  4. Review and develop SAS macros, templates, and utilities for data cleaning and reporting, and analyze specified tasks in the protocol or SAP.
  5. Participate in data review activities, review CRF annotations, and discuss data structures.
  6. Provide input into statistical programming solutions and/or ensure their efficient implementation, and consult with the Biostatistician on programming specifications.
  7. Maintain up-to-date knowledge of programming software (e.g., SAS) and industry requirements (e.g., CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings, and trainings.
  8. Establish successful working relationships with external associates according to agreed contracts and internal business guidance, and perform quality control on final reports.

Required Skills and Qualifications

Technical / Functional Skills

  • A strong understanding of applied parametric and non-parametric statistics, including Mixed Model, Missing Data analysis, General Linear models - ANOVA, ANCOVA, t-test, etc., Non-Parametric methods - Binomial test, Chi-Squared test, Wilcoxon tests; Logistic regression.
  • Expertise in R programming skills in R software, advanced SAS, and other statistical computing software skills in a clinical data environment across multiple therapeutic areas.
  • Good knowledge of CDISC implementation (SDTMs, ADaMs).

Minimum Requirements

  • A Master's degree in Statistics with 6+ years of work experience in a programming role preferably in clinical trials or the pharmaceutical industry or CROs.
  • Good SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables.

Salary: $120,000 - $150,000 per annum



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