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Harmony Biosciences, LLC
Associate Director, Biostatistics
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What they do
A Biostatistics Manager or Director manages a team of statisticians and directs statistical analysis and reporting of health and biology-related data. Analysis may be used for product development at a pharmaceutical company, disease research at a hospital or health policy research at a public health organization. Directs the design of statistical analysis and reviews analysis and findings; may manage regulatory reporting for projects such as clinical trials.
$180,355 / year median in Pennsylvania
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 neededContributes to the development and evaluation of technical infrastructure to facilitate efficient execution and evaluation of clinical trialsContributes to the selection, implementation and execution of statistical methodologies and related processesReviews 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 bodiesInteracts with and supports the Clinical teams interactions with clinical investigators, as needed, to determine protocol designEvaluates 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
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 dateGenerous paid time off and Company designated Holidays Company paid Disability benefits and Life Insurance coverage 401(k) Retirement Savings PlanPaid Parental leave Employee Stock Purchase Plan (ESPP) Company sponsored wellness programs Professional development initiatives and continuous learning opportunitiesA certified Great Place to Work for eight consecutive years based on our positive, values-based company culture Want to see our latest job opportunities? Follow us on LinkedIn! 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.comHarmony 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.
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 neededContributes to the development and evaluation of technical infrastructure to facilitate efficient execution and evaluation of clinical trialsContributes to the selection, implementation and execution of statistical methodologies and related processesReviews 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 bodiesInteracts with and supports the Clinical teams interactions with clinical investigators, as needed, to determine protocol designEvaluates 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:
Masters Degree in Biostatistics required, PhD preferred5+ years of experience in applying statistical methods in biomedical research 3+ years of pharmaceutical and/or CRO experience required3+ years of ADaM experience requiredExperience with all stages of clinical development, especially late stage experience strongly preferredAdvanced and broad knowledge of statistical methods, along with thorough understanding of industry practices related to the statistical analysis of clinical dataAdvanced knowledge in a variety of statistical methods with applications in clinical developmentExperience 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 plusExperience in all aspects of statistics for clinical trials and in working as a member of a project team including design of clinical studiesStrong understanding of the various functions and expert groups contributing to Drug DevelopmentStrong 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 dateGenerous paid time off and Company designated Holidays Company paid Disability benefits and Life Insurance coverage 401(k) Retirement Savings PlanPaid Parental leave Employee Stock Purchase Plan (ESPP) Company sponsored wellness programs Professional development initiatives and continuous learning opportunitiesA certified Great Place to Work for eight consecutive years based on our positive, values-based company culture Want to see our latest job opportunities? Follow us on LinkedIn! 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.comHarmony 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.