Clinical Trials Biostatistician and SAS Programmer

2 days ago

Bengaluru, Karnataka, India beBeeStatistical Full time ₹ 15,00,000 - ₹ 25,00,000

Job Opportunity:

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We are seeking a skilled Biostatistician and SAS Programmer to join our team. As a Biostatistician cum Statistical Programmer, you will be responsible for performing biostatistical and SAS programming activities for clinical trials involving Novel, Biosimilar and PMS studies.

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You will work on a variety of projects while collaborating with our cross-functional team of experts, developing your statistical skills, gaining exposure to multiple therapeutic areas, contributing to research design and analytical strategies, providing input into protocols, Statistical Methodology, and developing and reviewing statistical analysis plans.

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You will leverage your SAS programming skills to support Phase I-IV clinical trials, utilizing expertise in CDISC implementation (SDTMs, ADaMs) & TFLs, and experience in Regulatory Submissions as part of the Statistical Programming.

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Responsibilities:

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  • Provide SAS programming support to all clinical projects (Phase 1 to 4), managing programming CROs and providing oversight for programming deliverables. Create programming-related SOPs as necessary.
  • Work with CRO's Biostatistics and SAS Programming and Data Management teams on various clinical projects.
  • Provide statistical input into and review of statistical deliverables (analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for integrated reports).
  • Perform data manipulation, analysis, and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming, creating and validating datasets/analysis files, tables, listings, and figures (TLFs). Generate complex ad-hoc reports for publications.
  • Review and develop SAS macros, templates, and utilities for data cleaning and reporting, working with biostatisticians to implement specified analyses.
  • Review CRF annotations and data specifications, discuss data structures, and participate in data review activities.
  • Contribute to assigned parts of process improvement, standardization, and other non-clinical initiatives.
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Technical / Functional Skills:

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  • Knowledge of applied parametric and non-parametric statistics, 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.
  • Strong SAS/R programming skills, including 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).
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Minimum Requirements:

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  • Masters degree in statistics with ideally 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.

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