Manager, Biostatistics Job Description

Manager, Biostatistics Job Description

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Manager, biostatistics provides SAS programming and statistical analyses for publications and presentations of secondary study results of clinical trials.

Manager, Biostatistics Duties & Responsibilities

To write an effective manager, biostatistics job description, begin by listing detailed duties, responsibilities and expectations. We have included manager, biostatistics job description templates that you can modify and use.

Sample responsibilities for this position include:

Interacts with SAS programmers in the coordination of data summaries and analysis activities
Develop and maintain clinical reporting capabilities for both specialty disease states
Provide leadership, hands on training and oversight to the Clinical Analytics team
Work with various lane leaders to develop and refine reporting needs for internal and external customers
Validate data collection and reporting results
Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports
Monitors project progress and ensures proper resource allocation
Participates in project teams for clinical development programs for local projects or global projects in an established area and/or lifecycle management of marketed products, under supervision of TA statistician
Ensures efficient planning, execution and reporting of clinical studies
Ensures quality and consistency of key data science deliverables across studies within a project

Manager, Biostatistics Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Manager, Biostatistics

List any licenses or certifications required by the position: DFCI, PMP, ADP, ASQ

Education for Manager, Biostatistics

Typically a job would require a certain level of education.

Employers hiring for the manager, biostatistics job most commonly would prefer for their future employee to have a relevant degree such as Master's and Doctoral Degree in Biostatistics, Statistics, Medical, Mathematics, Education, Graduate, Biotechnology, Public Health, Applied Statistics, Management

Skills for Manager, Biostatistics

Desired skills for manager, biostatistics include:

Drug development process and FDA regulations
SAS and clinical biostatistics
SAS
Statistical principles
Applications
SAS programming software
Along with understanding of industry practices related to drug development
Clinical trial design and analysis
R
Statistical applications and programming languages

Desired experience for manager, biostatistics includes:

Ability to accept a high degree of authority and responsibility for major decision-making as it relates to the statistical programming of domestic and international clinical trials
Excellent judgment and ability to interpret national and international reporting regulations and protocol requirements, and initiate appropriate actions given competing priorities
PhD in statistics or biostatistics with 5 years relevant experience in the pharmaceutical industry or M.S
Experience supporting publication of analysis results
Bachelor's degree or equivalent in statistics, biostatistics, mathematics, computer science or related field or Bachelor’s degree in communications or education
Minimum 5 years in biostatistics/programming, clinical research or related experience

Manager, Biostatistics Examples

1

Manager, Biostatistics Job Description

Job Description Example
Our company is searching for experienced candidates for the position of manager, biostatistics. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manager, biostatistics
  • Leads the data science deliverable teams
  • Ensures availability of integrated database(s) where needed, plans and conducts integrated analyses to support development decisions, submissions or marketing needs
  • Trains and coordinates statisticians within a project or a set of studies
  • May under guidance and supervision, represent the company on statistical matters at meetings with regulatory authorities, key opinion leaders and similar experts/bodies
  • Reviews protocols to ensure statistical integrity and optimal study designs
  • Reviews and provides input into critical documents as Study Team Member, such as CRFs and Data Validation Plans
  • Implements study analyses, including reviewing SDTM/ADaM data specifications, providing programmers with efficacy analyses algorithms, programming or QCing inferential statistical analyses and reviewing outputs and analysis results
  • Leads and organizes review meetings, such as TLF review meetings, data review meetings and classification meetings
  • Writes (executive) topline reports with minimal guidance from global statistics lead
  • Contributes to clinical study reports and provides statistical interpretation of the results
Qualifications for manager, biostatistics
  • Experience working with pharmaceutical industry databases for regulatory submission preferred
  • Certification in Adult Learning preferred
  • Text Ability to train, coach and mentor others
  • Experience designing, developing, maintaining and implementing staff development programs
  • Excellent organizational and analytical problem-solving skills
  • High degree of confidentiality with clinical data and client’s proprietary data
2

Manager, Biostatistics Job Description

Job Description Example
Our company is looking to fill the role of manager, biostatistics. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for manager, biostatistics
  • Work with management to determine resource requirements
  • Participate in user requirements, process development and standardization
  • Provides strategic guidance and in-depth critical review for the development of Case Report Forms (CRFs) and database designs
  • Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports
  • Valid study design and statistical analysis of clinical trials, preclinical studies and Agensys research experiments
  • Statistical analysis of clinical trials and proper understanding of clinical study design
  • Technical leadership with clinical study team
  • Presenting statistical issues within Agensys and to external partners
  • Staff hiring, vendor selection and management of the Biostatistics group including statistical programmers
  • Mentoring more junior statisticians
Qualifications for manager, biostatistics
  • MS/MPH in biostatistics or a related field strongly preferred
  • Familiarity with survival analysis and longitudinal data analysis required
  • Ability to act as a study or department resource for Biostatistics & Programming processes
  • Must be able to set and work to timelines or be able to recognize and schedule changes in response to project demands
  • Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, global SOPs and client expectations
  • Knowledge of the drug development process and regulatory guidance
3

Manager, Biostatistics Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of manager, biostatistics. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, biostatistics
  • Trains and coordinates statisticians within a project or set of studies
  • Participates in writing the protocols of clinical studies to ensure that that the data collected may be used to reach valid conclusions about the hypotheses under investigation
  • Closely collaborates with project and study team members
  • May manage other individuals in functional area
  • Provide leadership and support in area of expertise to US and/or Global project teams
  • Identify and monitor state-of-the-art tools & industry practices
  • Oversees study design and sample size planning
  • Proactively align the department’s capabilities with the business strategy and product portfolios
  • Drive global standardization (e.g., CDISC) and alignment with other business areas, global divisional quality standards and compliance to global regulatory requirements
  • Ensure close, collaborative working relationships with study managements, regulatory affairs, medical & scientific affairs, and key outside contacts including CROs, KOL’s and/or members of partnering team
Qualifications for manager, biostatistics
  • Minimum seven (7) years of experience in of the technical areas required
  • Demonstrate knowledge of research principles, design and strategies, bio-statistical analyses and data interpretation
  • MS or PhD in Biostatistics, Statistics or a related field
  • Good understanding of study design (parallel group, crossover, observational studies) and statistical analysis methods (e.g., GLMs, non-parametric methods, survival analysis techniques, general imputation methods, common descriptive techniques)
  • Excellent mathematical skills and problem solving skills
  • Demonstrates a thorough working knowledge with industry standards such as ICH guidance, CDISC standards, 21 CFR Part 11, and regulatory guidelines
4

Manager, Biostatistics Job Description

Job Description Example
Our company is searching for experienced candidates for the position of manager, biostatistics. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manager, biostatistics
  • Responsible for the transfer of data from the data management company, cleaning and merging the data into workable data sets
  • Interacts with other collaborators to merge the primary dataset with other data sources
  • Performs the primary analyses under the direction of CSPH Faculty
  • Assures that projects are proceeding according to plan and helps develop recording systems assuring the flow of data is tracked in an accurate and timely fashion
  • Works as a Lead Analyst within the Center for Surgery and Public Health (CSPH)
  • Provides statistical support to CSPH Faculty and, if time and resources permit, other Faculty members as necessary to the CSPH mission and vision
  • Designs and performs analyses
  • Meets with study investigators regularly to review the execution of study design and data collection performs interim statistical analysis
  • Oversees the work of other analysts (up to 20% time)
  • Oversees execution of statistical analyses, preparation of the statistical methods and results sections for clinical investigation reports, and production of overall summaries (e.g., annual reports, Clinical Evaluation Reports)
Qualifications for manager, biostatistics
  • Experience with various clinical databases, including EDC systems
  • Contributes to the company's continuous improvement efforts
  • Member of external industry or professional organizations
  • Investigates new statistical methodology and gives feedback to department
  • Minimum of 5 years of experience in applying statistical methods in biomedical research, pharmaceutical or CRO industry experience required
  • Advanced knowledge of statistical methods for design of clinical studies and analysis of clinical data
5

Manager, Biostatistics Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of manager, biostatistics. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manager, biostatistics
  • Develops systematic documentation of methods, results and statistical programming
  • Assists in the design and testing of clinical databases and will consult with product development teams providing statistical expertise on new design features
  • Participates in meetings with regulatory authorities and external advisors to coordinate the transfer of and review of data (CROs, central laboratories)
  • Develops SOPs, dept procedure documents as required for functions within the role, ensuring consistency in statistical methodology, programming standards, and data specifications with all studies
  • Collaborates with Science, Engineering to develop statistically based verification and validation acceptance criteria and analyzing field data to provide insight into trends, and Regulatory in defining strategic approach and with Clinical in producing Clinical Investigation Plans and Case Report Forms
  • Provides statistical methodology for study protocols including sample size estimation, power calculation, and study design/conduct
  • Plans all aspects of data analysis
  • Coordinate and ensure quality-controlled production of all tables, listings, and graphs for the clinical documents (study reports, publications, regulatory submissions, etc) and work closely with programmers to provide specifications for report tables and listings
  • Reviews edit checks and Data Management Plans
  • Provides Randomization schema for treatment assignment
Qualifications for manager, biostatistics
  • Ability to interact across different cultures, builds global relationships
  • Accurate and keen eye for detail
  • Collaborative teamwork and interpersonal skills that demonstrate initiative and motivation
  • Experience in pharmaceutical clinical development in at least one therapeutic area
  • Basic to advanced pharmacokinetic knowledge regarding applicable variables, calculation methods, and statistical analyses/programming of these variables
  • Experienced in reporting databases and ADaM datasets

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