Associate Director, Biostatistics

Replimune; Woburn (MA); On-site; USD 194,000 - 251,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Flexible PTO

Year-end holidays

Job summary

Replimune Group, Inc. in Woburn, MA, is seeking an Associate Director, Biostatistics to provide statistical support across clinical trials and ensure endpoints meet regulatory requirements.

Responsibilities include leading biostatistics for studies, writing sections of reports, and guiding CRO activities. PhD or MS in Biostatistics or Statistics is required; oncology trial experience preferred.

Qualifications

• PhD or MS in Biostatistics or Statistics required.
• At least 3 years (PhD) or 5 years (MS) as statistician in pharma/biotech.
• Oncology trial experience preferred.
• Knowledge of advanced study design and up-to-date methodologies.
• Experience with regulatory submissions (NDA/BLA) preferred.

Responsibilities

• Provide assistant statistical support to compound statistical leader for clinical development plan for clinical trials.
• At study level, provide statistical input to study protocols, develop SAPs, and monitor databases.
• Lead biostatistics for assigned studies, publications, and presentations as needed.
• Contribute to writing sections of clinical study reports and publications.
• Coordinate with biometrics team and CROs on timelines and deliverables.
• Assist in pre-IND and NDA/BLA activities.
• Use SAS for efficacy analyses and data derivations.
• Develop and implement department standards and process improvements.

Skills

Interpersonal skills

Leadership

Communication skills

SAS knowledge

Statistical methods

Education

PhD or MS in Biostatistics or Statistics

Tools

SAS

SDTM

ADaM

Job description

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

The Associate Director, Biostatistics, provides statistical support in one or more clinical trials. Performs statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical development team to support protocol design. Evaluates databases and statistical analysis programs. Maintains expertise in state-of-the‑art data statistical methodologies and statistical analyses. At the project level, the individual in this role ensures the study designs are scientifically sound and that the efficacy and safety endpoints meet regulatory requirements.

• This position can be based either in our Woburn office or be a remote role
  • Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 15-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

Key responsibilities:

• Provide assistant statistical support to compound statistical leader for clinical development plan for clinical trials
• At study level, provide statistical input to study protocols, develop statistical analysis plan, tables/listings/figures, and database monitoring and lock activities
• Serve as biostatistics lead for assigned clinical studies, publications, and conference presentations, as needed
• Assist in writing relevant sections of the clinical study report and publications
• Monitor and guide internal biometrics team and CRO project activities including timelines, deliverables and resources
• Participate in pre-IND and NDA/BLA activities
• Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
• Develop and implement department standards and lead process improvements

Other Responsibilities:

Other duties as assigned

Education Requirements:

PhD or MS in Biostatistics or Statistics required

Experience and Skill Requirements:

• At least three (3) years’ experience for PhD, or five (5) years’ experience for MS as statistician in the pharmaceutical or biotechnology industry.
• Oncology (especially solid tumor) clinical trial experience preferred.
• Knowledge of advanced study design and up-to-date biostatistical methodologies.
• Experience of NDA/BLA eCTDs or other global regulatory submissions preferred.
• Experience as an independent statistician with responsibility for multiple studies or projects.
• Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively.
• Good knowledge of statistical programming languages (including SAS).
• Knowledge of SDTM/ ADaM.

Salary Range

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $193,500-$250,500The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance‑based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti‑tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus‑mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.