Senior Biostatistician II

4 weeks ago

Atlanta, United States Mindlance Full time

Job Title: Senior Biostatistician II
Job Location: REMOTE


MUST HAVES/ Top Skills:

· Lead level experience to react to FDA questions.

· Experience on ADaM Datasets and produce and review TLF shells.

· Submission experience.

· Preferred: submission response experience – rapid response.

SUMMARIZED PURPOSE:

· Serves as a project lead or lead statistician to deliver on tasks/responsibilities for multiple complex

· protocols, projects, or NDA projects, including coordinating with other divisions and interacting with the client and regulatory agencies. Mentors others in the application of more complex statistical

· methodologies. Performs project management functions relating to the administrative and scientific

· activities of team members across multiple complex projects. Provides senior-level oversight of statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians.

· Represents the department to clients on simple to complex study design matters, directly contributing to simple to complex study proposals and bids and representing the department at bid defences.

· Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies.

ESSENTIAL FUNCTIONS AND OTHER JOB INFORMATION:

Essential Functions

· Ensures compliance with the activities outlined in the department's SOPs and contribute changes as needed. Follows departmental procedures for statistical analyses and programming work.

· Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across challenging projects; provides senior review on projects. Leads team members across multiple complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.

· Reviews sample size calculations and protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Reviews randomization related documentation.

· Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis. Reviews statistical analysis for key efficacy endpoints.

· Reviews specifications for analysis database, oversees its development, and assures completeness for use in all programming. Oversees collaboration with programmers and data management personnel as to database maintenance, updating, and documentation. Supervises creation of table and listing specifications.

· Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.

· Monitors project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope.

· Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management.

· Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, contributing to performance planning, and providing resource planning.

· Provides input on hiring recommendations, department policies, and resourcing requirements.

· Acts as representative of the department to other divisions. Assists in bidding and business development activities. Consults with business development with respect to bids and timelines.

· Job Complexity Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

· Job Knowledge A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.

Supervision

· Received Normally receives little instruction on day-to-day work, general instructions on new

· assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Business Relationships

· Represents the department as a prime contact on projects. Interacts with internal

· and external personnel on significant matters often requiring coordination between

· functional areas. Networks with senior internal and external personnel in own area

· of expertise.

EDUCATION AND EXPERIENCE:

· Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’).

· Master's degree in statistics, biostatistics, mathematics or related field

· In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the

· requirements of the role.



  • Senior Biostatistician II

    2 weeks ago

    Atlanta, United States Mindlance Full time

    Job Title: Senior Biostatistician II Job Location: REMOTE MUST HAVES/ Top Skills: · Lead level experience to react to FDA questions. · Experience on ADaM Datasets and produce and review TLF shells. · Submission experience. · Preferred: submission response experience – rapid response. ...

  • Senior Biostatistician II

    1 month ago

    Atlanta, United States Mindlance Full time

    Job Title: Senior Biostatistician II Job Location: REMOTE MUST HAVES/ Top Skills: · Lead level experience to react to FDA questions. · Experience on ADaM Datasets and produce and review TLF shells. · Submission experience. · Preferred: submission response experience – rapid response. ...

  • Senior Biostatistician II

    1 week ago

    Atlanta, United States Mindlance Full time

    Job Title: Senior Biostatistician II Job Location: REMOTE MUST HAVES/ Top Skills: Lead level experience to react to FDA questions. Experience on ADaM Datasets and produce and review TLF shells. Submission experience. Preferred: submission response experience rapid response. SUMMARIZED PURPOSE: ...

  • Contract Biostatistician- Remote, Inflammation, Immunology or Oncology

    4 weeks ago

    Atlanta, United States PharmaBiotech Company Full time

    Contract Biostatistician- Remote, Inflammation, Immunology or Oncology experience a must.Our client is a top tier pharmaceutical company is seeking contract Biostatistician’s for their Oncology and I&I groups. This role will involve implementing and executing methodological and statistical aspects of clinical studies under the supervision of a lead...

  • Contract Biostatistician- Remote, Inflammation, Immunology or Oncology

    2 weeks ago

    Atlanta, United States PharmaBiotech Company Full time

    Contract Biostatistician- Remote, Inflammation, Immunology or Oncology experience a must.Our client is a top tier pharmaceutical company is seeking contract Biostatistician’s for their Oncology and I&I groups. This role will involve implementing and executing methodological and statistical aspects of clinical studies under the supervision of a lead...

  • Sr Biostatistician

    4 weeks ago

    Atlanta, United States Mindlance Full time

    Job Title: Sr Biostatistician Job Location: Remote Top 3/5 Skills: 1) Biostatistics, Statistical Analysis Plans 2) SAS Programming 3) ADAM Data Sets 4) FDA Submissions Job Description: Summarized Purpose: Serves as a subject matter expert and lead in providing statistical, process and regulatory knowledge to the department. Acts as...

  • Sr Biostatistician

    1 month ago

    Atlanta, United States Mindlance Full time

    Job Title: Sr Biostatistician Job Location: Remote Top 3/5 Skills: 1) Biostatistics, Statistical Analysis Plans 2) SAS Programming 3) ADAM Data Sets 4) FDA Submissions Job Description: Summarized Purpose: Serves as a subject matter expert and lead in providing statistical, process and regulatory knowledge to the department. Acts as...

  • Sr Biostatistician

    2 weeks ago

    Atlanta, United States Mindlance Full time

    Job Title: Sr Biostatistician Job Location: Remote Top 3/5 Skills: 1) Biostatistics, Statistical Analysis Plans 2) SAS Programming 3) ADAM Data Sets 4) FDA Submissions Job Description: Summarized Purpose: Serves as a subject matter expert and lead in providing statistical, process and regulatory knowledge to the department. Acts as...

  • Sr Biostatistician

    1 week ago

    Atlanta, United States Mindlance Full time

    Job Title: Sr Biostatistician Job Location: Remote Top 3/5 Skills: 1) Biostatistics, Statistical Analysis Plans 2) SAS Programming 3) ADAM Data Sets 4) FDA Submissions Job Description: Summarized Purpose: Serves as a subject matter expert and lead in providing statistical, process and regulatory knowledge to the department. Acts as the...

  • Sr. Sales Analyst

    3 weeks ago

    Atlanta, United States Kids II Full time

    At Kids2, we're really good at what we do. And when we're great at our jobs, we help parents be great at their jobs. Parenting is demanding, and that's where we come in. We want to reimagine how brands can make it easier for early stage parents - not by just selling them products, but by providing holistic solutions that transcend borders, categories and...

  • Sr. Sales Analyst

    1 week ago

    Atlanta, United States Kids II Full time

    At Kids2, we're really good at what we do. And when we're great at our jobs, we help parents be great at their jobs. Parenting is demanding, and that's where we come in. We want to reimagine how brands can make it easier for early stage parents - not by just selling them products, but by providing holistic solutions that transcend borders, categories and...

  • Internal Auditor II

    3 weeks ago

    Atlanta, United States Federal Home Loan Bank of Atlanta Full time

    Compensation Grade: 08 OUR VISION FOR DIVERSITY AND INCLUSION: FHLBank Atlanta contributes to our members' success through a diverse, inclusive, and engaged culture that enables all individuals to work together to fulfill our purpose. BASIC PURPOSE: Independently and under the general supervision of a more senior auditor, the Auditor II performs audit...

  • Internal Auditor II

    1 month ago

    Atlanta, United States Federal Home Loan Bank of Atlanta Full time

    Compensation Grade: 08 OUR VISION FOR DIVERSITY AND INCLUSION: FHLBank Atlanta contributes to our members' success through a diverse, inclusive, and engaged culture that enables all individuals to work together to fulfill our purpose. BASIC PURPOSE: Independently and under the general supervision of a more senior auditor, the Auditor II performs audit...

  • Internal Auditor II

    1 day ago

    Atlanta, United States FHLBank Atlanta Full time

    Compensation Grade: 08 OUR VISION FOR DIVERSITY AND INCLUSION: FHLBank Atlanta contributes to our members' success through a diverse, inclusive, and engaged culture that enables all individuals to work together to fulfill our purpose. BASIC PURPOSE:   Independently and under the general supervision of a more senior auditor, the Auditor II performs...

  • Internal Auditor II

    2 weeks ago

    Atlanta, United States Federal Home Loan Bank of Atlanta Full time

    Compensation Grade: 08 OUR VISION FOR DIVERSITY AND INCLUSION: FHLBank Atlanta contributes to our members' success through a diverse, inclusive, and engaged culture that enables all individuals to work together to fulfill our purpose. BASIC PURPOSE: Independently and under the general supervision of a more senior auditor, the Auditor II performs audit...

  • Senior Accountant II

    3 weeks ago

    Atlanta, United States Beazer Homes Full time

    Prepares monthly journal entries. Posts transactions to journals, ledgers and other records. Reconciles specified general ledger account to supporting documentation. Assists with monthly variance analysis to prior periods and forecasts, researches an Accountant, Senior, Accounting, Operations, Construction

  • Portfolio Manager II

    3 days ago

    Atlanta, United States Bank of America Full time

    Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we deliver for our clients, teammates, communities and shareholders every day. One of the keys to driving Responsible Growth is being a great place to work for...

  • Senior Mechanical Engineer

    2 weeks ago

    Atlanta, United States CRB Full time

    Job Description The Mechanical Engineer IV is responsible for overseeing the discipline at a project level and managing the project discipline budget on simple to complex projects of all sizes. This candidate will have a thorough understanding of the development and field implementation of documents through all project phases. They will possess the ability...

  • Site Reliability Engineer Senior II

    4 days ago

    Atlanta, United States Akamai Full time

    Do you like collaborating across teams to solve complex problems?Do you enjoy solving large scale distributed content delivery challenges?Join our highly skilled Site Reliability teamOur team designs, develops, and manages applications and infrastructure that support Akamai's Compute products and services. We do this while maintaining Akamai's mission at the...

  • Senior physical Design engineer

    2 weeks ago

    Atlanta, United States Healthcare InfoTech Full time

    Remote job Rate: 70-73 per hour We are looking for a highly skilled Senior Physical Design Engineer with extensive experience in Block/SOC level PD implementation flow. The ideal candidate will possess strong technical expertise in physical design processes and a proactive attitude toward problem-solving and project completion. Key Responsibilities: •...