Eikon Therapeutics
Senior Manager, Statistical Programming
Eikon Therapeutics, Jersey City, New Jersey, United States, 07390
Position
The Senior Manager of Statistical Programming will be accountable for statistical programming deliverables in Eikon clinical studies. In this role, you will report to the Sr. Director of Statistical Programming. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California, New York or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You will oversee and manage the statistical programming deliverables for clinical studies, ensuring that they meet quality, compliance, and timeliness requirements. The role requires collaboration with various stakeholders, including Biostatistics, Clinical Research, Regulatory, Clinical Safety, Data Management, and PK/PD Modeling.
What You’ll Do
Be responsible for statistical programming deliverables in multi-disciplinary interactions
Provide development, review and approval for statistical programming documents, oversight vendor programming work to ensure high quality as well as operational excellence
Have In-depth understanding of CDISC standards (SDTM, ADaM, Define.xml, etc.) and apply corresponding knowledge to develop ADaM specifications, SAS programs and review regulatory electronic submission packages
Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publications
Support statistical programming quality control process and develop functional Standard Operating Procedures (SOPs) and Work Instructions
Support the development of CRFs, edit checks, review of Data Transfer Specifications, and any other collaborations with Data Management function
Qualifications
Post Graduate degree with 6+ years of experience or a
B
achelor's
degree
with 8+ years of experience
in a relevant field (e.g., statistics, biostatistics, computer science, or a related discipline).
Expertise in SAS and clinical trial programming; Experience in R is a plus
Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards based on quality, compliance and timeliness requirements
US of worldwide drug regulatory application submission experience including the development of electronic submission deliverables
Experience in CDISC and ADaM standards
Demonstrated success in the assurance of deliverable quality and process compliance
Excellent interpersonal skills and ability to negotiate and collaborate effectively
Recent experience working in the field of oncology preferred but not required
Experience developing and implementing statistical programming standards preferred but not required
Experience developing JReview reports to support medical monitoring preferred but not required
Strong working knowledge of reporting processes (e.g., SOPs) and statistical computing environments preferred but not required
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.
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The Senior Manager of Statistical Programming will be accountable for statistical programming deliverables in Eikon clinical studies. In this role, you will report to the Sr. Director of Statistical Programming. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California, New York or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You will oversee and manage the statistical programming deliverables for clinical studies, ensuring that they meet quality, compliance, and timeliness requirements. The role requires collaboration with various stakeholders, including Biostatistics, Clinical Research, Regulatory, Clinical Safety, Data Management, and PK/PD Modeling.
What You’ll Do
Be responsible for statistical programming deliverables in multi-disciplinary interactions
Provide development, review and approval for statistical programming documents, oversight vendor programming work to ensure high quality as well as operational excellence
Have In-depth understanding of CDISC standards (SDTM, ADaM, Define.xml, etc.) and apply corresponding knowledge to develop ADaM specifications, SAS programs and review regulatory electronic submission packages
Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publications
Support statistical programming quality control process and develop functional Standard Operating Procedures (SOPs) and Work Instructions
Support the development of CRFs, edit checks, review of Data Transfer Specifications, and any other collaborations with Data Management function
Qualifications
Post Graduate degree with 6+ years of experience or a
B
achelor's
degree
with 8+ years of experience
in a relevant field (e.g., statistics, biostatistics, computer science, or a related discipline).
Expertise in SAS and clinical trial programming; Experience in R is a plus
Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards based on quality, compliance and timeliness requirements
US of worldwide drug regulatory application submission experience including the development of electronic submission deliverables
Experience in CDISC and ADaM standards
Demonstrated success in the assurance of deliverable quality and process compliance
Excellent interpersonal skills and ability to negotiate and collaborate effectively
Recent experience working in the field of oncology preferred but not required
Experience developing and implementing statistical programming standards preferred but not required
Experience developing JReview reports to support medical monitoring preferred but not required
Strong working knowledge of reporting processes (e.g., SOPs) and statistical computing environments preferred but not required
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.
#J-18808-Ljbffr