Biostatistical Programmer

Biocon Biologics Limited; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

A leading company in the biopharmaceutical industry seeks a Biostatistician cum Statistical Programmer to support clinical trials. This role involves using SAS and R programming for data analysis and contributing to regulatory submissions in various therapeutic areas. Ideal candidates will have a Master's degree and significant programming experience.

Qualifications

• 4+ years experience in a programming role, ideally in clinical trials.
• Proven SAS experience in developing and validating deliverables.

Responsibilities

• Provide SAS programming support for all clinical projects (Phase 1 to 4).
• Perform data manipulation, analysis, and reporting of clinical trial data.
• Review and develop SAS macros, templates, and utilities for data cleaning.

Skills

SAS programming

R programming

Applied statistics

Education

Master's degree in statistics

Job description

Biostatistician cum Statistical Programmer

Job Description

Performs biostatistical and SAS programming activities for clinical trials involving Novel, Biosimilar, and PMS studies. As a Biostatistician cum Statistical Programmer, you'll work on various projects, collaborating with our cross-functional team of experts. You'll develop your statistical skills, gain exposure to multiple therapeutic areas, contribute to research design and analytical strategies, and provide input into protocols and statistical analysis plans. As a Statistical Programmer, 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 as part of the Statistical Programming team. This role supports a growing pipeline across multiple therapeutic areas, with an emphasis on regulatory submissions.

Responsibilities

1. Provide SAS programming support for all clinical projects (Phase 1 to 4). Manage programming CROs, overseeing programming deliverables. Create programming SOPs as needed. Collaborate with CROs' Biostatistics, SAS Programming, and Data Management teams.
2. Provide statistical input and review of deliverables such as analysis plans, table shells, programming specifications, data review, tables, listings, figures, and statistical sections for reports.
3. Perform data manipulation, analysis, and reporting of clinical trial data, both safety and efficacy, using SAS programming. Create and validate datasets/analysis files, tables, listings, and figures (TLFs). Generate complex ad-hoc reports for publications.
4. Review and develop SAS macros, templates, and utilities for data cleaning and reporting. Ensure the implementation of analyses specified in protocols or SAPs, working closely with biostatisticians.
5. Review CRF annotations and data specifications, discuss data structures, and participate in data review activities.
6. Provide input into statistical programming solutions and ensure their efficient implementation. Review programming specifications of analysis datasets and pooled datasets in consultation with biostatisticians.
7. Maintain up-to-date knowledge of SAS software and industry standards (e.g., CDISC SDTM/ADaM, eCTD, Define.xml). Attend functional meetings and training sessions.
8. Establish successful working relationships on individual studies with external partners according to contracts and internal guidelines. Perform quality control on final reports, ensuring the accuracy of statistical programming components in scientific reports and publications.
9. Contribute to process improvements, standardization, and other non-clinical initiatives.

Technical / Functional Skills

Knowledge of applied parametric and non-parametric statistics, including Mixed Models, Missing Data analysis, ANOVA, ANCOVA, t-tests, and non-parametric methods such as Chi-Squared, Wilcoxon tests, and Logistic regression. Strong SAS and R programming skills in a clinical data environment across multiple therapeutic areas. Good knowledge of CDISC standards (SDTMs, ADaMs).

Minimum Requirements

Master's degree in statistics with ideally 4+ years of experience in a programming role, preferably in clinical trials, pharmaceutical industry, or CROs. Proven SAS experience in developing and validating deliverables within a statistical programming environment.