Head of Statistical Programming US

Waltham, MA, United States

Job Description

We are looking for someone to lead and develop the North American team as well as providing mentoring, support and professional development to individual members of the Statistical Programming Team. In addition, work as Statistical Programmer providing communication skills and expertise in the preparation of regulatory, clinical, and marketing documents throughout drug development, post-marketing and life-cycle management.

Key Responsibilities

Management of the US Statistical Programming Team according to Sobi’s values including development of the staff and the department to meet Sobi’s business needs

Provide leadership and project coordination to all statistical programmers working in the project, including in-house consultants and statistical programmers at CRO

Prepare the clinical components of regulatory submissions, e.g. Clinical Overviews, Summaries of Clinical Efficacy and Safety, Briefing documents, regulatory response documents, Clinical Study Reports and Investigator’s Brochures

Ensure communication of a clear, concise, complete, credible and compelling scientific content aligned with the objective of a regulatory document

Support clinical studies with programming skills

Support and drive company projects, data and programming standards together with the Head of Statistical Programming

Be the System owner for the new Statistical Programming Environment

Collaborate with full SEDS to support and enhance project activities

Scope of the Job (define the job as it relates to the larger scheme of the organization)

Ensure timely, high quality deliverables from Statistical Programming in accordance with project milestones and in line with the overall Sobi RDMA project portfolio priority

Responsible for processing of clinical data required for analysis of clinical trials, Phase I-IV.

Create/acquire tools to improve programming efficiency or quality.

Create/review programming plan, specifications for datasets and TLFs.

Support data request from other functional group (Statistical Science, Medical Writing, MACD, Drug Safety, Regulatory and Marketing).

Act as mentor for junior staff by giving lessons, advices and challenging their SAS code

** Principal Interfaces / Relationships **

List the titles of individuals with whom this position interacts, both inside and outside the organization.

_ Internal :_

Clinical Data Manager

Product Statistician

Study Statistician

Statistical Programmer

Medical Writer

Clinical Program Leader

Clinical Study Manager

Medical Director Lead

Medical Program Lead

Drug Safety Manager and Physician

Regulatory Affairs Manager

Clinical Pharmacologist

Marketing

IT

QA

Patient Access

_ External : _

Programmers and other personnel at external service providers

Qualifications:

Qualifications

** Education/Learning Experience **

_ Required :_

Bachelor of Science (BSc) in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas.

** Desired: **

Master of Science (MSc) or PhD

** Work Experience **

** Required: **

A minimum of 10-year experience of drug development within pharmaceutical industry and/or a Contract Research Organization (CRO)

Experience of regulatory submission with FDA, EMA or PMDA

Excellent written and verbal Communication skills in English

** Desired: **

A minimum of 5 years of experience of Statistical Programming or similar

Successful track-record of leading complex projects

A minimum of 2 years of experience in managing statistical programmers

** Skills/Knowledge **

** Required: **

Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment, in particular clinical trial data setting and clinical submissions (Base SAS, SAS Macro and SAS Graph)

Familiar with CDISC conventions, i.e. SDTM and ADaM models and related controlled terminologies, and knowledge or some experience using these models

Familiar with common external coding dictionaries (MedDRA and Standard MedDRA Queries, SMQ and WHO DD), knowledge or some experience of other external dictionaries (e.g. SNOMED, WHOART, COSTART and UNII)

Excellent oral and written communication skills

Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results

** Desired: **

Extensive knowledge in CDISC data standards and controlled terminology

Excellent application and macro development skills

** Personal Attributes **

** Required: **

Highly developed analytical and strategic thinking with an ability to identify key issues

A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds

Sense of accountability and ownership and able to work independently

Good project management and organizational skills

High scientific and ethical integrity

Curiosity and drive to broaden skill and knowledge

** Desired: **

Excellent leader with strong interpersonal and influencing skills

** Languages **

_ Required _ : English, both oral and written communication

_ Desired :_ Swedish or French, both oral and written communication

Other Areas of Responsibilities : To participate in departmental activities, e.g. SOP writing, as required

Additional Information

The base salary pay range for this role is $XXX,XXX - $XXX,XXX annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

Reporting to

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected]

COVID-19 Policy

For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.

Qualifications

** _Education/Learning Experience_**

_ **Required** :_

* Bachelor of Science (BSc) in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas.

** _Desired:_**

* Master of Science (MSc) or PhD

** _Work Experience_**

** _Required:_ **

* A minimum of 10-year experience of drug development within pharmaceutical industry and/or a Contract Research Organization (CRO)

* Experience of regulatory submission with FDA, EMA or PMDA

* Excellent written and verbal Communication skills in English

** _Desired:_ **

* A minimum of 5 years of experience of Statistical Programming or similar

* Successful track-record of leading complex projects

* A minimum of 2 years of experience in managing statistical programmers

** _Skills/Knowledge_**

** _Required:_**

* Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment, in particular clinical trial data setting and clinical submissions (Base SAS, SAS Macro and SAS Graph)

* Familiar with CDISC conventions, i.e. SDTM and ADaM models and related controlled terminologies, and knowledge or some experience using these models

* Familiar with common external coding dictionaries (MedDRA and Standard MedDRA Queries, SMQ and WHO DD), knowledge or some experience of other external dictionaries (e.g. SNOMED, WHOART, COSTART and UNII)

* Excellent oral and written communication skills

* Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results

** _Desired:_**

* Extensive knowledge in CDISC data standards and controlled terminology

* Excellent application and macro development skills

** _Personal Attributes_**

** _Required:_**

* Highly developed analytical and strategic thinking with an ability to identify key issues

* A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds

* Sense of accountability and ownership and able to work independently

* Good project management and organizational skills

* High scientific and ethical integrity

* Curiosity and drive to broaden skill and knowledge

** _Desired:_**

* Excellent leader with strong interpersonal and influencing skills

** _Languages_**

_ **Required**_ : English, both oral and written communication

_ **Desired** :_ Swedish or French, both oral and written communication

**Other Areas of Responsibilities** : To participate in departmental activities, e.g. SOP writing, as required

Additional Information

The base salary pay range for this role is $XXX,XXX - $XXX,XXX annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

**Reporting to**

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

**Why Join Us?**

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

**Sobi Culture**

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

**An Equal Opportunity Employer**

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

_Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to[[email protected]](mailto:[email protected])_

**COVID-19 Policy**

For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.

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