Associate Director of Statistical Programming

Role Overview & Key Functions:

The Associate Director of Statistical Programming leads the programming work in the Statistical Programming Group.

RESPONSIBILITIES:

• Reviews and understands study documents, including the Protocol, electronic case Report Forms (eCRFs) and Statistical Analysis Plans (SAPs).
• Reviews and understands raw electronic Common Technical Document (eCTD) database structure.
• Participates in Statistical Analysis Plan (SAP) development and review.
• Participates in Tables, Listings and Figure (TLF) shells development and review.
• Driver of Statistical Programming projects.
• Leads 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 Clinical Data Standards Consortium (CDISC) validation software to ensure SDTM and ADaM datasets comply with regulations.
• Oversees vendors for outsourced statistical programming work.
• Mentors less experienced programmers.
• Trains new programmers on Karyopharm SOPs and best practices.
• Represents the Statistical Programming Group at cross functional team meetings.
• Interviews Biostatistics and Statistical Programming candidates.

Candidate Profile & Requirements:

• > 12 – 18 years of clinical trials experience.
• BS in Mathematics, Statistics or related field preferred.
• MS/PhD in Biostatistics, Public Health or related field preferred.
• Expertise in SAS required.
• R or other statistical software a plus.
• Experience in support of electronic submissions in eDTC format required.
• Experience with CDISC data standards SDTM and ADaM preferred.
• Experience supporting an Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE) required.
• Experience in management of Statistical Programmers preferred.

At Karyopharm, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity. We maintain broad salary ranges to reflect market conditions and the specialized nature of our work. The anticipated base salary range for this position is $175K - $200K USD.

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), 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 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