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Lead Biostatistician and Statistical Programmer
1 week ago
Job Summary
We are seeking a skilled Lead Biostatistician and Statistical Programmer to join our team at Biocon Biologics. This is an exciting opportunity for a talented individual to work on a variety of projects, collaborating with cross-functional teams of experts.
About the Role
- As a Lead Biostatistician and Statistical Programmer, you will be responsible for performing biostatistical and SAS programming activities for given clinical trials involving novel, biosimilar, and PMS studies.
- You will work closely with our cross-functional team 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.
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.
- Work in tandem with CRO's 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.
- Apply your SAS programming skills to 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/analyze specified in the protocol or the Statistical Analysis Plan (SAP) is 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 of 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 relationships 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).
Requirements
- 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.
