Director, Biostatistics

Aclaris Therapeutics - Wayne, PA (30+ days ago)4.5


We are Aclaris Therapeutics – committed to meeting the needs of patients with skin and hair conditions with innovative treatments that define new standards of care in dermatology and immunology.

Reporting to the Chief Medical Officer, this position is responsible for leading the statistical strategy, execution, and Data Management.

Their work will be in all phases of clinical drug development and will require working with a broad group of functions, e.g. biologists, regulators, marketers and clinical scientists.
Their work will be a key factor in ensuring Aclaris delivers medicines using the best, most efficient and high-quality methods.
The role recognizes the value of statistical thinking and the Director will be a key function driving the design and overall strategy of clinical research.
In addition to driving the statistical strategy, the Director will manage the teams responsible for Data Management. These teams are likely to be external to Aclaris for the near and medium term.
The Director will be responsible for identifying the resource needs and building the team needed to deliver the statistical and Data Management strategy.

Responsibilities
Use statistical strategy to advise and guide clinical teams to deliver efficient and high quality research.
Responsible for all statistical aspects of a clinical development project
Planning, coordination, prioritization and implementation of statistical aspects of research, e.g. biomarker-guided clinical development, pharmacogenomics, pharmacokinetics, pharmacodynamics, dose finding, clinical development in Phase IIb, III, IV and regulatory submission.
CRF/EDC development
Applying innovative study designs and developing statistical milestone criteria (e.g. Go/No Go criteria).
Development of clinical trial protocols and statistical analysis plans, statistical oversight of trial conduct, interpretation of results and preparation of clinical trial reports, submission documents, global value dossiers, local reimbursement dossiers, and publications.
Lead data management and ensure high quality data
Programming
Be familiar with and be able to support SDTM and ADaM datasets
Qualifications
Masters and/or Doctoral degree in Statistics or Mathematics
Thorough knowledge of statistical methodology, processing clinical trial information, the drug development process, GCP and regulatory guidelines
Able to demonstrate experience working as a trial and project statistician in clinical development
Substantiated knowledge in the application of statistical software solutions (SAS)
Ability to communicate statistical information to non-statisticians
Good project management skills
Excellent communication and presentation skills to interact with authorities and external bodies (specialists as well as non-specialists) on statistical-methodological issues
Thorough knowledge of adaptive designs, Bayesian methodology, causal inference, mediation analysis, and trial simulation would be an advantage

Physical Requirements:
The usual and customary methods of performing the job's functions require the following physical demands: some lifting, carrying, pushing, and/or pulling; some stooping, kneeling, crouching, and/or crawling; and significant fine finger dexterity. Generally the job requires 80% sitting, 10% walking, and 10% standing. This job is performed in a generally clean and healthy environment.

What We Provide:
At Aclaris Therapeutics, we are proud to offer if eligible, a highly competitive compensation plan with an excellent benefits package including the following:

Company Sponsored Insurance: Medical, Dental, Vision, Life Insurance, AD&D Insurance Short-Term Disability and Long-Term Disability
3 Weeks Paid Vacation
14 Paid Holidays
401(k) with a generous match!
On-site Gym with personal trainer, free for employees!
Fun environment!
Free Snacks Daily!
Pizza Friday – free for employees!
Catered lunches and other fun events!
Hands-on management to provide comprehensive training and professional development
Advancement opportunities
Modern office in beautiful corporate park with access to parks, shopping and restaurants

Location:
640 Lee Road

Wayne PA 19087

Hours:
Standard hours

9:00AM-5:00PM, Monday-Friday

Aclaris Therapeutics, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity.