Biostatistician/Statistical Programmer

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization.

About the role- 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 a 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' 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). • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming. Applying your SAS programming skills, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s). Generating complex ad-hoc reports for publications. • Reviews/Develops SAS macros, templates and utilities for data cleaning and reporting. Reviews/ analyses specified in the protocol or the Statistical Analysis Plan (SAP) is implemented while working with the biostatisticians. • Reviews 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 relationship on individual studies with external associates according to agreed contract and internal business guidance. Performs quality control on final reports. Ensures the accuracy of statistical programming components of scientific reports and/or publications with high quality. • Contributes 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).

Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.