Senior Biostatistician

Location: Remote, CA based company. Must overlap core PT working hours, and accommodate any meetings and urgent deliverables during PT hours.

SUMMARY

A biopharmaceutical company in the Bay area needs the support of a Senior Biostatistician for 6+ month renewable project. This is an organization has a rapidly expanding pipeline primarily focused on the treatment of rare genetic diseases. This consultant will be supporting statistical activities for clinical trials such as contribution to trial designs, authoring statistical sections of protocols, preparing SAPs, and reviewing and interpreting the analysis of clinical trial data. They must have direct experience with multiple imputation, especially with prior submissions, as they will work on the model, write code, and be able to help programming team members as needed with any questions.

DUTIES & RESPONSIBILITIES

Contribute to study design, protocol development, sample size calculation, CRFs, Results Interpretation, clinical study report, and addressing questions from regulatory agencies. Collaborate with vendor to develop and maintain SAPs, including the derived variables, the templates of statistical TFLs Provide guidance to the study team for all statistical activities while collaborating with a data manager to ensure high-quality data Work collaboratively with cross functional teams to ensure timelines are being met Manager CROs by establishing procedures through regular interaction, setting expectations on deliverables and timelines to guide vendor biostatisticians and statistical programmers Provide input for regulatory interaction or by writing the interaction document; may participate in meeting or teleconferences with Health Authorities Coordinate with all team members to prepare the statistical analyses for IB, DSUR update, periodic safety updates, and other ad hoc safety analyses; participate in cross-functional study-related activities, attend team meetings

QUALIFICATIONS & REQUIREMENTS

PhD in Biostatistics/Statistics or related field and at least 4+ years of biostatistics experience in pharma (Small to mid-sized companies is ideal) OR MS in Biostatistics/Statistics or related field and at least 7+ years of pharma experience Must have Multiple Imputations experience (MI) Must possess strong statistical programming technical expertise in SAS Recent submissions experience - preferable to have experience in Phase III and late phase clinical trials Experience providing CRO/vendor oversight, ensuring deliverables and timelines are being met Knowledge of statistical methodologies, current drug development trends, and regulatory environments Ability to communicate effectively and interact with cross functional teams #J-18808-Ljbffr Redbock - an NES Fircroft company