Director of Statistical Programming

Who We Are

Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer.

The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such non-responsiveness or acquired and intrinsic resistance.

Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine.

The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines. Come join us to help improve lives.

For more information, visit www.kinnate.com and follow us on LinkedIn.

Your Impact at Kinnate

The Director of Statistical Programming is a key member of the clinical team who will be responsible for building the statistical programming function by designing and establishing standards and processes to ensure high quality and timely deliverables.

Key Responsibilities:

The Director is responsible for proposing strategic approach and hands-on support to produce and prioritize deliverables for multiple clinical studies by implementing strategies, managing internal and external resources to actualize department and company goals. This person will build the programming function through hiring and mentoring junior members and oversee/QC deliverables produced by CRO. Lead process improvement efforts and motivate and lead a team of vary levels of status and ability. This person works closely with cross-functional teams including clinical development, biostatistics, safety/pharmacovigilance, clinical biomarker, translational, and data management colleagues on various clinical projects and data explorations. The Director is responsible for liaising with data management and other functions to enhance the integrity of data (i.g. security and confidentiality). This position reports to the Head of Biometrics.

The Right Stuff

MS in data science related field (e.g. Statistics, Mathematics, Epidemiology and Computer Science) or related field required
10+ years’ experience of statistical programming preferably in analysis of clinical trial data, minimum 2 years of management experience.
Experience building the data infrastructure and processes to meet regulatory requirements in filling (IND, NDA, BLA etc)
Experience in managing technical professionals or CRO in regulated environment
Proficient in SAS software and programming concepts and techniques in the pharmaceutical industry
Experience with Spotfire or virtualization tools is highly desirable
Experience in using Medidata data extraction tools
Experience of leading early and late-phase clinical studies including programming and validation of SDTM and ADaM datasets, and TFLs
Proficient in industry standards (CDSIC, SDTM and ADaM), medical terminology, safety data and coding dictionaries (MedDRA and WHODD)
Possesses project management skills within the statistical programming function
Experience in working with clinical lab data, biomarker data, PK data are highly desired
Strong leadership, teamwork, and communication skills (verbal and written)
Strong problem solving and analytical skills
Regulatory (FDA and EMA) submission experience, creating programming files required to support and electronic submission in eCTD format

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

We offer a competitive total rewards package that provide our employees with the resources to pursue their goals, both at work and in their personal lives. The salary reasonably expected to be paid for this role is $216,000 to $230,000. The actual compensation and seniority level for this position will be determined based on relevant experience and qualifications. This position is eligible for an annual cash bonus and equity awards. Our employees are also eligible to receive other benefits including:

· Unlimited Paid Time Off

· 10 Company Paid Holidays - plus 2 annual paid “Refresher Days”

· Wide variety of comprehensive health, dental, and vision packages – most with minimal to no out-of-pocket expenses for employees

· Company contribution to 401k plan

· Employee stock purchase program

· Annual Massage Days

· Free local gym memberships

· Healthy Lifestyle Reimbursement Program

· Home Office Reimbursement Program

Kinnate recognizes the importance of balance and flexibility in our work environment. Physical presence at the Kinnate worksites or physical presence in the field is an essential job function of this role which the company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the company culture.

Kinnate is proud to be responsible members of our communities. Subject to applicable law, we require all our employees to be fully vaccinated and boosted against the COVID-19 virus. Therefore, all applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.

EEO & Employment Eligibility

Kinnate Biopharma Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Kinnate Biopharma Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of applicable law.

Recruitment & Staffing Agencies: Kinnate Biopharma Inc. does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Kinnate or its employees is strictly prohibited unless contacted directly by Kinnate’s internal HR Team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Kinnate, and Kinnate will not owe any referral or other fees with respect thereto.