Principal, Biostatistician

Karyopharm Therapeutics

Karyopharm Therapeutics

Data Science
United States · Remote
Posted on Tuesday, June 11, 2024

Principal, Biostatistician

Job Locations US-Remote
Job ID
2024-2283
# of Openings
1
Category
Research and Development
Type
Regular Full-Time

Role Overview & Key Functions:

  • Accountable for all statistical aspects of protocols and regulatory submissions for clinical development programs.
  • Represent Karyopharm regarding statistical issues with external parties including regulatory agencies and corporate partners
  • Work with clinical, pharmacovigilance, and regulatory personnel in preparation of statistical documents (e.g., statistical analysis plans) and analyses (e.g., safety and efficacy analyses) to support DSMB/DMC meetings, Development Safety Update Reports, and investigative brochures.
  • Work with data management personnel in the preparation of data sets that are of high quality and in usable format.
  • Work with medical writing personnel in preparation of clinical study reports and other regulatory documents including NDA
  • Work with publications and data analytics personnel in the preparation of meeting abstracts/presentations and analytical reports of preliminary data from ongoing clinical studies.
  • Effectively interact with members of other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
  • Proactively mentors and trains subordinates to continually improve processes and procedures in support of internal and external customers.
  • Guide team in the design and analysis of clinical studies using appropriate and innovative statistical methods.
  • Depending on resource needs, assign tasks and supervise the work of external contract statisticians and programmers.
  • Review draft presentations and training materials, including posters and slide decks, according to deadlines

Candidate Profile & Requirements:

  • PD. in Statistics or Applied Mathematics or related fields
  • 4 plus years’ experience of clinical research and drug development
  • Demonstrated ability to effectively contribute to the statistical aspects of clinical protocol design, data interpretation, review and reporting of results for multiple studies and projects.
  • Practical experience with application of advanced statistical methodologies to clinical trial design/analysis and with regulatory reporting/submissions.
  • Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development.
  • Strong written verbal and written communication skills.
  • Ability to communicate statistical information to non-scientists, willingness to educate internal team.
  • Ability to work in a fast-paced environment.
  • Adept at outsourcing and managing biostatistical services provided by CRO’s and/or contractors.

Our Value Proposition:

At Karyopharm, we live and demonstrate our ICARE values every day!

If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission.

Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between.

What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.

Check out our Culture Video!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), teamembers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

  • A culture of employee engagement, diversity, and inclusion
  • Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
  • Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
  • Wellness Program with a monthly stipend.
  • Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
  • Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
  • Cell phone allowance
  • In the U.S., the salary range for this position is $165K to $185K per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors

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