Lead Biostatistician

Role: Lead Biostatistician Consultant
Timeline: 6+ months Renewable
Location: Remote, CA based company.
SUMMARY:
A biopharmaceutical company in the Bay area needs the support of a Lead 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:
Lead clinical trials and 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 10+ years of pharma experience
Must have Multiple Imputations experience (MI)
Must have experience as study lead
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

Work arrangement
No