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Join to apply for the Sr. Statistical Programmer role at Katalyst CRO 6 months ago Be among the first 25 applicants Join to apply for the Sr. Statistical Programmer role at Katalyst CRO Get AI-powered advice on this job and more exclusive features. 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. 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. 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 possess strong statistical programming technical expertise in SAS. 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Statistical Programmer” roles. Statistician III, Duke-Margolis Institute for Health Policy - Hybrid Washington DC or Durham NC Durham, NC $131,300.00-$243,900.00 2 weeks ago Durham, NC $131,300.00-$243,900.00 2 weeks ago FSP Principal Biostatistician- Early Phase Clinical Development(PK) Durham, NC $115,900.00-$243,900.00 3 weeks ago Durham, NC $122,800.00-$233,400.00 2 days ago Cary, NC $73,000.00-$112,000.00 1 week ago Morrisville, NC $80,600.00-$145,000.00 1 month ago Principal Statistical Programmer, Early Phase Durham, NC $106,200.00-$218,000.00 2 weeks ago Principal Statistical Programmer, Standards We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr