Associate Director, Biostatistics

Harmony Biosciences; Harmonville (PA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical Vision Dental

Paid time off

401(k) plan

Parental leave

ESPP

Wellness programs

Professional development

Great Place to Work

Job summary

Harmony Biosciences is seeking an Associate Director of Biostatistics to join the Clinical Biostatistics team in Plymouth Meeting, PA. You will ensure statistical soundness of input and deliverables across late-stage studies and collaborate with regulatory authorities.

You will partner with Clinical teams on trial design, apply advanced methods, contribute to standards, and lead complex projects while keeping current with regulatory guidance and new statistical methodologies.

Qualifications

• Master's Degree in Biostatistics required; PhD preferred.
• 5+ years applying statistical methods in biomedical research.
• 3+ years in pharmaceutical or CRO environments.
• 3+ years of ADaM experience.
• Experience with late-stage development is strongly preferred.
• Strong SAS programming skills; R knowledge is a plus.

Responsibilities

• Support statistical elements of study design, analysis, and decision-making.
• Develop and evaluate infrastructure to facilitate trials.
• Select and implement statistical methodologies and processes.
• Review project documents for statistical presentation and compliance.
• Contribute to standards for variables, data structures and presentation.
• Prepare statistical aspects for meetings with regulators and KOLs.
• Interact with clinical investigators to determine protocol design.
• Evaluate databases and analysis tools for optimal solutions.
• Stay updated with new methods and regulatory guidance.

Skills

Statistical methods

SAS

R programming

Biostatistics

Regulatory knowledge

Education

Master's Degree in Biostatistics

PhD preferred

Job description

Harmony Biosciences is recruiting for an Associate Director, Biostatistics in our Plymouth Meeting location. In this role you will work within the Clinical Biostatistics team to ensure accurate information processing for data integrity, quality, and efficiency. Manages complex projects, supports interactions with regulatory authorities and key opinion leaders, and is accountable for the statistical soundness of all statistical input and deliverables for assigned projects. Partners with the Clinical team on clinical trial design and available statistical methodologies and their application in drug development. Participates in the development and application of standards and process improvement within the Clinical Biostatistics team.

Responsibilities include but are not limited to:

• Actively supports clinical development teams on statistical elements of study design, analysis and decision-making issues. Advises on available statistical methodologies, performs modeling and simulations, and leverages external experts, as needed
• Contributes to the development and evaluation of technical infrastructure to facilitate efficient execution and evaluation of clinical trials
• Contributes to the selection, implementation and execution of statistical methodologies and related processes
• Reviews key project and study documents to ensure optimal statistical presentation and compliance
• Facilitates and oversees creation of standards with respect to key variables, definitions, statistical methods, data structures and presentation of data
• Contributes to the preparation of statistical aspects for meetings with regulatory authorities, key opinion leaders and similar experts and bodies
• Interacts with and supports the Clinical teams' interactions with clinical investigators, as needed, to determine protocol design
• Evaluates databases and statistical analysis programs to determine optimal technical solutions
• Maintains awareness of new methodology in statistics and updates in regulatory guidelines, and signals relevant developments in a timely manner for the project teams

Qualifications:

• Master's Degree in Biostatistics required, PhD preferred
• 5+ years of experience in applying statistical methods in biomedical research
• 3+ years of pharmaceutical and/or CRO experience required
• 3+ years of ADaM experience required
• Experience with all stages of clinical development, especially late stage experience strongly preferred
• Advanced and broad knowledge of statistical methods, along with thorough understanding of industry practices related to the statistical analysis of clinical data
• Advanced knowledge in a variety of statistical methods with applications in clinical development
• Experience in statistical and data requirements for health authorities such as FDA; experience in statistical and data requirements for European regulatory bodies and PMDA is a plus
• Experience in all aspects of statistics for clinical trials and in working as a member of a project team including design of clinical studies
• Strong understanding of the various functions and expert groups contributing to Drug Development
• Strong programming skills in SAS; proficiency with R programming is a plus

Physical demands and work environment:

• Domestic travel is estimated to be up to 5% of the time for this position.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• While performing the duties of this job, the noise level in the work environment can vary from relatively quiet (remote or office) to moderate.
• The employee must be able to occasionally lift and/or move more than 20 pounds.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.

What can Harmony offer you?

• Medical, Vision and Dental benefits the first of the month following start date
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• A certified Great Place to Work for eight consecutive years based on our positive, values-based company culture

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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com

Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.