Planet Pharma
Study Lead Statistician – Product Facing
Apply for the Study Lead Statistician - Product Facing role at Planet Pharma.
CO/NYC candidates might not be considered.
Responsibilities
Provide statistical guidance, review, and contribution to protocols, SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review, and other communications.
Attend and contribute at Clinical Study Team Meetings and provide statistical input into cross‑functional study start‑up activities, including CRF development, database specifications review, database development, and IVRS specification review.
Initiate cross‑functional team meetings as necessary (e.g., SAP review, TFL shell review).
Provide statistical guidance, review, and be responsible for statistical analysis of individual studies/projects.
Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as programmatic statistical analyses of these endpoints.
Perform data‑driven modeling during clinical studies.
Review TFLs created by statistical programming for consistency and accuracy.
Author analysis reports such as Flash Memo and the results section of CSRs.
Collaborate with the study programming team for study deliverables.
Manage timelines for all statistics‑related deliverables by working with cross‑functional team members (programmers, study statisticians, clinical data managers, medical writers).
Support product‑level publication requests.
Maintain familiarity with all company policies, SOPs and other controlled documents related to study activities.
Assist with study and system audits conducted by Company GCA and external bodies.
Minimum Qualifications
Master’s degree in Statistics/Biostatistics or related field with at least 4 years of post‑graduate statistical experience in the pharmaceutical industry or medical research (or PhD with at least 3 years experience).
Strong skill in communicating statistical information clearly and concisely (written and oral).
Strong understanding of statistical concepts related to the design and conduct of clinical studies.
Strong ability to apply statistical methodologies in the analysis of clinical trials.
Independent leadership of the design, analysis, and reporting of at least one complex or multiple less‑complex studies/projects within a Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia.
Previous experience in the development, authoring, and execution of protocols and SAPs, as well as review of CSRs.
Excellent oral and written English communication skills.
Strong SAS and/or R programming skills in conducting simulations and applying statistical concepts and methods based on complex study designs.
Preferred Qualifications
Master’s degree in Statistics/Biostatistics or related field with at least 6 years of post‑graduate statistical experience in the pharmaceutical industry or medical research, or Doctoral degree with at least 5 years of post‑graduate experience.
Experience designing, analyzing, and reporting clinical trials within Pharmaceutical/Biotechnology/Public Health settings in Industry, Government or Academia.
Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) and at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings.
Demonstrated ability to work in cross‑functional teams, ideally including projects focused on delivering business solutions and collaborating with clinical development colleagues in study management, programming and IS.
Experience in publication support.
The Planet Group of Companies is an equal‑opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr
CO/NYC candidates might not be considered.
Responsibilities
Provide statistical guidance, review, and contribution to protocols, SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review, and other communications.
Attend and contribute at Clinical Study Team Meetings and provide statistical input into cross‑functional study start‑up activities, including CRF development, database specifications review, database development, and IVRS specification review.
Initiate cross‑functional team meetings as necessary (e.g., SAP review, TFL shell review).
Provide statistical guidance, review, and be responsible for statistical analysis of individual studies/projects.
Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as programmatic statistical analyses of these endpoints.
Perform data‑driven modeling during clinical studies.
Review TFLs created by statistical programming for consistency and accuracy.
Author analysis reports such as Flash Memo and the results section of CSRs.
Collaborate with the study programming team for study deliverables.
Manage timelines for all statistics‑related deliverables by working with cross‑functional team members (programmers, study statisticians, clinical data managers, medical writers).
Support product‑level publication requests.
Maintain familiarity with all company policies, SOPs and other controlled documents related to study activities.
Assist with study and system audits conducted by Company GCA and external bodies.
Minimum Qualifications
Master’s degree in Statistics/Biostatistics or related field with at least 4 years of post‑graduate statistical experience in the pharmaceutical industry or medical research (or PhD with at least 3 years experience).
Strong skill in communicating statistical information clearly and concisely (written and oral).
Strong understanding of statistical concepts related to the design and conduct of clinical studies.
Strong ability to apply statistical methodologies in the analysis of clinical trials.
Independent leadership of the design, analysis, and reporting of at least one complex or multiple less‑complex studies/projects within a Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia.
Previous experience in the development, authoring, and execution of protocols and SAPs, as well as review of CSRs.
Excellent oral and written English communication skills.
Strong SAS and/or R programming skills in conducting simulations and applying statistical concepts and methods based on complex study designs.
Preferred Qualifications
Master’s degree in Statistics/Biostatistics or related field with at least 6 years of post‑graduate statistical experience in the pharmaceutical industry or medical research, or Doctoral degree with at least 5 years of post‑graduate experience.
Experience designing, analyzing, and reporting clinical trials within Pharmaceutical/Biotechnology/Public Health settings in Industry, Government or Academia.
Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) and at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings.
Demonstrated ability to work in cross‑functional teams, ideally including projects focused on delivering business solutions and collaborating with clinical development colleagues in study management, programming and IS.
Experience in publication support.
The Planet Group of Companies is an equal‑opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr