Principal Biostatistician (PL)

Principal Biostatistician

Currently at Barrington James, we are working closely with our Poland based client, who are looking for a Permanent Principal Biostatistician to become a valuable asset to their team.

Job Details

1. Title: Principal Biostatistician
2. Start date: ASAP
3. Salary: €80,000 - €90,000 depending on experience
4. Location: Poland (Fully remote)

Essential duties and responsibilities

1. Statistical Expertise: Possess a strong understanding of statistical principles and demonstrate strong statistical skills. Provide comprehensive statistical support throughout clinical studies.
2. Statistical Analysis and Interpretation: Conduct statistical analyses of clinical data and interpret the results, focusing on the efficiency and safety of drug molecules or study goals.
3. Study Design and Reporting: Experienced in calculating sample sizes, developing concepts and protocols for studies, creating Statistical Analysis Plans (SAP), and preparing clinical study reports, including integrated summaries for regulatory submissions.
4. Regulatory Engagement: Engage with regulatory bodies such as the FDA and EMEA, preparing statistical documentation and effectively communicating statistical plans and results in professional forums.
5. DMC/DSMB Support: Provide support for Data Monitoring Committees/Data Safety Monitoring Boards (DMC/DSMB), including charter development, SAP, and mock Tables, Listings, and Figures (TLFs) for DSMB support. This encompasses interim analysis, TLF shells, both blinded and unblinded reports, and organizing kick-off meetings.
6. Regulatory Submission Standards: Solid understanding and implementation of Clinical Data Interchange Standards Consortium (CDISC) requirements for regulatory submissions, including experience with Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) specifications generation and quality control of datasets.
7. SAS Proficiency: Extensive hands-on experience in statistical analysis using SAS, including creating mock shells for tables, listings, and figures (TLFs), and validating TLFs for New Drug Applications (NDA) and Biologics License Applications (BLA) submissions.
8. Client Interaction and Sales Support: Actively engage with clients to understand their statistical and analytical needs, providing expert advice and solutions. Support the sales cycle by contributing to proposals, presentations, and discussions that showcase our statistical capabilities and how they meet client requirements.
9. SOP Development: Responsible for the creation and updating of Standard Operating Procedures (SOPs) related to statistical processes and regulatory submissions.

Required Experience and Education

1. MSc or PhD in Biostatistics/Statistics
2. 10+ years of experience as a Biostatistician, working within a CRO/Pharma/Biotech.
3. 3+ years of experience in leading a team of Biostatisticians and Statistical Programmers.
4. Strong written and verbal communication skills, including proficiency in the English language.
5. Must have experience/expertise - CDISC, SAS, R & Python
6. FDA/EMA experience
7. Proficient in BASE, STAT, MACRO and GRAPH and understanding of database structures, TLFs proficiency
8. Cross functional ability (Hands on with Ad-Hoc tasks when required)

If you are interested, please reach out to Louis Hall at Barrington James.