The  Principal Statistical Programmer will play a critical role in advancing clinical trial research and regulatory submissions. This position offers the opportunity to lead statistical programming efforts, including developing and validating datasets, creating files for regulatory submissions, and collaborating with cross-functional teams to ensure compliance with CDISC data standards. If you’re passionate about driving excellence in statistical programming and contributing to life-changing clinical development programs, this role provides the perfect platform to make a meaningful impact.

Reporting to our Senior Director, Statistical Programming   you will positively impact patients’ when you:

• Reviews and understands study documents, including the Protocol, electronic case Report Forms (eCRFs) and Statistical Analysis Plans (SAPs).
• Reviews and understands raw eDTC database structure.
• Participates in Statistical Analysis Plan (SAP) development and review.
• Participates in TLF shells development and review.
• Driver of Statistical Programming projects.
• Major contributor to the development of Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) dataset specifications.
• Leads projects in close partnership with Biostatisticians.
• Develops global standard macros to improve the efficiency of the Statistical Programming Group.
• Creates define.xml for regulatory submissions.
• Uses CDISC validation software to ensure SDTM and ADaM datasets comply with regulations.
• Oversees vendors for outsourced statistical programming work.
• Mentors less experienced programmers.
• Represents the Statistical Programming Group at cross functional team meetings.

• BS in Mathematics, Biostats/Statistics, Computer Science/Data Science or related field Required.
• MS/PhD in Biostatistics/Statistics/CS/Data Science, Public Health or related field preferred.
• 8 – 12 years of Phase 1-Phase 3 clinical trials conducted in biotech/pharmaceutical/CRO environment experience required. Experience in Oncology therapeutic area a plus.
• Expertise in SAS required.
• R or other statistical software a plus.
• Experience in support of electronic submissions in electronic Common Technical Document (eCTD) format a plus.
• Experience with Clinical Data Standards Consortium (CDISC) data standards SDTM and ADaM preferred.
• Experience supporting an Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE) a plus.

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), team members 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 Flex Time Off program 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 $160,000 to $175,000 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