Associate Director or Director, Biostatistics

Posted 19 Days Ago
Be an Early Applicant
Watertown, MA
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
As the Lead Statistician, you will oversee statistical efforts for a clinical program, contribute to the clinical development plan, author statistical sections for regulatory submissions, manage relationships with CROs, and support scientific publications. You will also ensure compliance with global regulatory standards and guide direct reports if applicable.
Summary Generated by Built In

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. 


How we work:

  • PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
  • COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
  • BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.


How you’ll contribute:

As the Lead Statistician, you will spearhead the statistical efforts of a clinical program, playing a key role in the clinical development plan, regulatory submissions, and overall data strategy. This role requires strategic involvement in program teams, authorship of statistical sections in study documents, and direct oversight of outsourced statistical functions.

  • Act as the lead statistician of a clinical program, leading statistical efforts and representing biometrics functions on program teams. Make strategic contributions to the clinical development plan.
  • Serve as the biostatistical lead for regulatory submissions and inspections, ensuring compliance with global regulatory standards.
  • Contribute to the development of clinical protocols by authoring the statistical methods section and reviewing other sections for statistical accuracy.
  • Develop and review statistical analysis plans for individual studies and integrated summaries of safety/efficacy (ISS/ISE). Create and edit statistical outputs shells.
  • Provide statistical input during CRF design to ensure alignment with study objectives and analyze requirements. Oversee and quality control results from statistical programmers or CROs.
  • Contribute to clinical study reports by authoring statistical sections and interpreting study results. Support the preparation of scientific publications and presentations.
  • Manage relationships with CROs to ensure high-quality statistical outputs and compliance with study requirements.
  • May manage direct reports, as needed, providing guidance and professional development.


Skills and experience you’ll bring:

  • Advanced degree in Statistics or related field with minimum 6 years of clinical trial experience in a biotechnology or pharma company.
  • Extensive knowledge of statistical methods for clinical trials and deep familiarity with FDA, EMA, and ICH guidelines.
  • Expertise in SAS required; R or Python is advantageous. Experience with trial design software such as EAST or nQuery.
  • Strong communication skills necessary for effective collaboration with cross-functional teams. Ability to communicate statistics to non-statisticians effectively; influence and ensure adoption of robust statistical methods.
  • Exceptional ability to manage multiple priorities in a fast-paced environment.
  • A strong passion for innovation in Biostatistics and continuous improvement in processes.
  • Strong analytical and problem-solving abilities.
  • Positive attitude and a collaborative spirit.


This position is based in Watertown, MA, and offers a hybrid work model with a minimum of 3 days/week in the office.


Skills and experience not an exact match?:

Go ahead and submit your resume (and a cover letter, if you’d like!).  If this role isn't right for you, we can keep you in mind for future opportunities.


                                                                                                                                                                                  


Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.


Top Skills

Python
R
SAS
The Company
Watertown, Massachusetts
208 Employees
On-site Workplace
Year Founded: 2016

What We Do

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years

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