Senior Biostatistician

Client note- They need someone who has small Pharma company experience. 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 question s. DUTIES & RESPONSIBILITI ES: Contribute to study design, protocol development, sample size calculation, CRFs, Results Interpretation, clinical study report, and addressing questions from regulatory agenc ies.Collaborate with vendor to develop and maintain SAPs, including the derived variables, the templates of statistical TFLsProvide guidance to the study team for all statistical activities while collaborating with a data manager to ensure high-quality dataWork collaboratively with cross functional teams to ensure timelines are being metManager CROs by establishing procedures through regular interaction, setting expectations on deliverables and timelines to guide vendor biostatisticians and statistical program mersProvide input for regulatory interaction or by writing the interaction document; may participate in meeting or teleconferences with Health Authori tiesCoordinate 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 meet ings QUALIFICATIONS & REQUIRE MENTS: 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 exp erienceMust have Multiple Imputations experien ce (MI)Must possess strong statistical programming technical expertise in SASRecent submissions experience - preferable to have experience in Phase III and late phase clinical trialsExperience providing CRO/vendor oversight, ensuring deliverables and timelines are be ing metKnowledge of statistical methodologies, current drug development trends, and regulatory envir onmentsAbility to communicate effectively and interact with cross functiona l teams