Senior Manager/Associate Director, Biostatistics

Role Summary

The Senior Manager/Associate Director, Biostatistics leads hands-on SAS programming for individual clinical studies and pooled analyses. The role provides CDISC dataset specifications, programs datasets, and outputs to support statistical plans and regulatory submissions. Location: Redwood City, CA.

Responsibilities

• Provide hands-on programming for individual study and pooled analyses conducted in-house
• Provide input into various study documents like the SAP, DMP, DVP, DTS
• Working knowledge of CDISC standards. Prepare SDTM and ADaM dataset specifications. Program datasets.
• Write programs to implement statistical plans for new studies or slight modifications of previously run analyses. Self-check programs by understanding interdependencies in the data or comparing with previously obtained results.
• Identify and communicate data issues encountered during stat deliverable programming to the appropriate parties.
• Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods.
• Work with urgency on responses to regulatory queries in collaboration with other statistical and programming colleagues.
• Contribute to the maintenance of the statistical computing environment to support global usage.
• Complete additional tasks and/or activities as requested and/or required to communicate results.
• Ensure the successful achievement of department and company goals.

Qualifications

• Strong knowledge of Base SAS, SAS/STAT, SAS macros, and SAS/GRAPH. Proficiency in quick visualization tools like Spotfire and JMP.
• Ability to communicate effectively both cross-functionally and within the programming function.
• Practical experience with CDISC standards such as CDASH, SDTM, ADaM, and Define-XML. Practical experience with validation software for standardized data (e.g. Pinnacle 21).
• Integrated Summary Safety / Efficacy Analyses; safety data and coding dictionaries – understanding of pooling practices.
• Good understanding of protocol design, study conduct, and clinical data flow.
• Interpersonal/teamwork skills for effective interactions.
• Project planning skills – ability to set timelines and intermediate milestones to track progress.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Work with external vendors and third-party organizations and provide oversight to outsourced work.

Education

• Master’s degree in Statistics or quantitative discipline with 6+ years of relevant Pharmaceutical/Biotech/CRO Industry clinical statistical analysis/programming experience or Bachelor’s degree with 8+ years.