Principal / Associate Director Biostatistician

Apex Systems

Cambridge, Massachusetts

Date Posted January 18, 2023
Industry Clinical Research
Specialty Not Specified
Job Status Not Specified
Salary Not Specified

Description:

Job#: 1310433

Job Description:
Principal/Associate Director Biostatistician 1310433

Location: Cambridge MA (Remote)

Science: ADCs

Therapeutics Areas: Oncology

Job Overview: The incumbent will be involved in the design, execution, analysis and reporting of clinical studies as well as gain experience in regulatory interactions.

Responsibilities:
Serve as the biostatistics leader and point-of-contact in multiple clinical development teams responsible for determining clinical study strategies and delivering results with high quality and on time.
Leader in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs.
Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types.
Participates in activities and meetings to support Biostatistics and the Development Team as needed
Develop statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses.

Qualifications:
PhD degree with 5+ (or master’s degree with 8+ years) of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations.
Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems.
Working knowledge of relevant FDA, EMA, ICH guidelines and regulations.
Experience working with CROs, vendors, and relationship management preferred.

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.

achan@stratacuity.com

Code: RegQA

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 employeeservices@apexsystems.com or 844-463-6178.

Employee Type:
Contract

Location:
Cambridge, MA, US

Job Type:
Scientific and Clinical

Date Posted:
November 15, 2022