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
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