Apex Systems Looking for Associate Director, Biostatistics at Boston, MA Full Time

Associate Director, Biostatistics (Remote) 1239947

Job Scope & Purpose:

Our long-term client is advancing an exciting pipeline of therapies for neurological disorders, with a particular focus on innovative treatments for epilepsy. They are looking for an experienced biostatistician to join their team. The Associate Director will play a key as their lead program advances toward an NDA submission. The role reports into the Sr. Director and could have direct reports in the future.

Primary Job Responsibilities:

• Serve as the lead statistician, review study protocols, develop or supervise the development of the statistical sections of protocols, statistical analysis plans and analysis specifications for the programming implementation of the statistical analyses.
• Collaborate with Clinical Science to develop innovative trial designs that align with the project strategy and that address statistical, medical, and/or operational issues.
• Provide statistical input into data management and programming deliverables to ensure that they support the protocol specified goals and statistical analyses.
• Manage CROs within area of responsibility ensuring the quality, accuracy, and timeliness of outsourced statistical deliverables.

Primary Job Requirements:

• Advanced degree in Statistics or Biostatistics with 8+ years’ of experience in the pharmaceutical or biotech industry
• Strong knowledge in advanced statistical methodologies related to clinical trial design, statistical modeling, and analysis
• Experience with multiple phases of clinical development and regulatory submissions
• Proficiency with the SAS programming language; knowledge of R or similar language a plus
• Knowledge of CDISC standards, including ADaM requirement
• Experience in CNS preferred
• Experience in CRO management

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Code: ClinOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .