Statistical Programmer

Biocon Biologics; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A leading pharmaceutical company in India is seeking a Global Talent Acquisition Specialist to perform SAS programming and biostatistical activities for various clinical trials. The ideal candidate has a Master's degree in statistics and at least 6 years of experience in a programming role, specifically in the pharmaceutical or CRO industries. This full-time role offers the opportunity to work on diverse projects collaborating with a cross-functional team of experts.

Qualifications

• Master's degree in statistics with ideally 6+ years of work experience in a programming role.
• Proven skills in SAS within a Statistical Programming environment.

Responsibilities

• Provide SAS programming support to clinical projects from Phase 1 to 4.
• Perform data manipulation, analysis and reporting of clinical trial data.
• Develop SAS macros, templates, and utilities for data reporting.

Skills

SAS programming

Biostatistics

Statistical analysis

Data manipulation

Clinical trials

Education

Master's degree in statistics

Tools

SAS

R

Job description

Global Talent Acquisition Specialist @BioconBiologics | End to End Recruitment | Pharma/Biotech

Biostatistician cum Statistical Programmer Job Description

Performs biostatistical and SAS programming activities for given clinical trials involving Novel, Biosimilar and PMS studies. As a Biostatistician cum Statistical Programmer you’ll work on a variety of projects, while collaborating with our cross-functional team of experts. You’ll be able to develop your statistical skills, gain exposure to multiple therapeutic areas. You’ll also contribute to research design and analytical strategies, provide input into protocols, Statistical Methodology and develop and review 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, will play a key role in supporting a growing pipeline across multiple therapeutic areas, with emphasis on regulatory submissions.

Responsibilities

• Provide SAS programming support to all clinical projects (Phase 1 to 4). Manage programming CROs providing oversight for programming deliverables. Create programming related SOPs, as necessary. Works in tandem with CRO Biostatistics and SAS Programming and Data Management teams on various clinical projects.
• Provide statistical input into and review of statistical deliverables (i.e. 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. Create and validate datasets/analysis files, tables, listings, and figures (TLFs). Generate complex ad‑hoc reports for publications.
• Review/Develop SAS macros, templates and utilities for data cleaning and reporting. Review/analyses specified in the protocol or the Statistical Analysis Plan (SAP) implemented while working with the biostatisticians.
• Review CRF annotations and data specifications & discuss data structures and participate in data review activities.
• Provide input into statistical programming solutions and/or ensure their efficient implementation. In consultation with the Biostatistician, responsible for reviewing programming specifications of analysis datasets and pooled datasets.
• Maintain up‑to‑date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
• Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance. Perform quality control on final reports. Ensure the accuracy of statistical programming components of scientific reports and/or publications with high quality.
• Contribute to assigned parts of process improvement, standardization and other non‑clinical initiatives. Technical / Functional Skills: 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 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).
• Master degree in statistics with ideally 6+ years of work experience in a programming role preferably clinical trials or in 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.

Qualifications

• Master degree in statistics with ideally 6+ years of work experience in a programming role preferably clinical trials or in 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.

Seniority level

Associate

Employment type

Full‑time

Job function

Health Care Provider

Industries

Pharmaceutical Manufacturing