HealthPlix - Biostatistician

Role Expectations -

As a statistician you will lead in-house statistical and analytical services in RWE studies, participate in RWE projects within Clinical Affairs and take part in cross-divisional collaborations with RWE relevance. Working with key stakeholders, the role will execute on key RWE deliverables, establish standards and drive automation for programming of statistical outputs, and demonstrate best practices with regard to transparency and reproducibility of statistical methods and processes used in RWE projects.

- Contribute to the development of RWE study design and protocols

- Create and oversee development of statistical analysis plans (SAPs) for RWE studies

- Perform the statistical programming and analyses for assigned RWE studies; write and validate programs to generate tables, listings, and figures and analysis datasets.

- Develop programs/macros to automate standard analyses and increase efficiencies

- Increase knowledge of statistical methods relevant to RWE and their implementation

- Identifies areas of improvement with RWE statistical workflows and data quality, and works to improve efficiencies and effectiveness

- Ensure processes (SOPs) and subsequent documentation of statistical processes is maintained.

- Participate in cross-functional / cross-divisional initiatives regarding RWE

- Work closely with the Medical writer to recommend statistical methodologies on publications.

Key skills and Background Requirements :

- Masters Degree in Statistics

- PhD, MSc or BSc in Biostatistics, Statistics, or related field

- 4+ years of experience as a statistician and/or statistical programmer with at least 2+ years direct experience using observational/real-world data (RWD) in the pharmaceutical sector.

- Thorough understanding of statistical, pharmacoepidemiology, and outcomes research methods used in real-world evidence (RWE) studies, observational and retrospective database studies, and healthcare utilization.

- Added advantage to have experience in leading analyses for RWE studies to meet regulatory requirements within the agreed upon budget, timeline, and resources.

- Experience with advanced statistical methods utilized for RWE studies (e.g., propensity score matching) and eagerness to continuously learn and expand statistical expertise.

- Expert in SAS programming. Working knowledge of other statistical / programming reporting tools is an advantage (e.g., R, STATA, python, SQL, Power BI, Tableau, Databricks), and familiarity with cloud computing.

- Experience with secondary data sources including registries and EMR data.

- Strong organizational skills, with ability to effectively and efficiently handle multiple tasks simultaneously, with precision, and adapt to changes in responsibilities and workloads