Katalyst CRO
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Principal Statistical Programmer
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Katalyst CRO 9 months ago Be among the first 25 applicants Join to apply for the
Principal Statistical Programmer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy). CDISC Standards: Proficiency in CDISC standards (SDTM & Adam) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents: You'll create and review submission documents and electronic case report forms (escorts). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group.
Responsibilities
SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy). CDISC Standards: Proficiency in CDISC standards (SDTM & Adam) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents: You'll create and review submission documents and electronic case report forms (escorts). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group.
Requirements
MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Experience: At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry (with a bachelor's degree) or 6 years with a master's degree or above. Expertise: Familiarity with statistical principles, CDISC data, and standards. Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus 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 Get notified about new Statistical Programmer jobs in
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Principal Statistical Programmer
role at
Katalyst CRO 9 months ago Be among the first 25 applicants Join to apply for the
Principal Statistical Programmer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy). CDISC Standards: Proficiency in CDISC standards (SDTM & Adam) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents: You'll create and review submission documents and electronic case report forms (escorts). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group.
Responsibilities
SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy). CDISC Standards: Proficiency in CDISC standards (SDTM & Adam) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents: You'll create and review submission documents and electronic case report forms (escorts). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group.
Requirements
MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Experience: At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry (with a bachelor's degree) or 6 years with a master's degree or above. Expertise: Familiarity with statistical principles, CDISC data, and standards. Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus 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 Get notified about new Statistical Programmer jobs in
Hayward, CA . San Francisco, CA $120,000.00-$155,000.00 4 days ago Part-Time Biostatistician / Statistical Programmer (CDISC SDTM/ADaM)
San Francisco, CA $140,000.00-$170,000.00 21 hours ago Oakland, CA $10,279.00-$11,900.00 1 day ago Mountain View, CA $141,000.00-$202,000.00 5 days ago San Francisco, CA $150,000.00-$200,000.00 3 days ago Livermore, CA $168,780.00-$256,824.00 7 hours ago South San Francisco, CA $120,000.00-$160,000.00 6 days ago Pleasanton, CA $95,400.00-$123,900.00 3 days ago Palo Alto, CA $175,000.00-$200,000.00 5 hours ago San Mateo, CA $120,000.00-$135,000.00 5 days ago San Francisco, CA $50,000.00-$120,000.00 2 weeks ago San Francisco, CA $130,000.00-$180,000.00 3 days ago Data Scientist III, Research, Ads Insight and Measurement
Mountain View, CA $141,000.00-$202,000.00 6 days ago Data Scientist III, Research, Search Ads
Mountain View, CA $141,000.00-$202,000.00 5 days ago San Francisco, CA $85,000.00-$120,000.00 5 hours ago Fremont, CA $145,000.00-$204,000.00 1 week ago Data Scientist - Research Analytics - Entry Level
Mountain View, CA $166,000.00-$244,000.00 1 week ago 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